Livecareer-Resume

Vice President Quality Assurance Resume Example

Love this resume?

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Professional Summary
Senior Quality Assurance Executive Biopharmaceuticals * Pharmaceuticals * Life Sciences Accomplished, compliance driven QA professional with over 19 years of progressive experience and proven record of significant, successful contribution in Pharmaceutical Quality Management Systems within the US and EU. Implemented Quality Program within R&D for conformance with phase appropriate cGMPs. As Site Head of Quality, responsible for the overall quality functions for the corporation. Formulated, prioritized, executed and drove the GMP quality strategy, communicated company's quality programs/vision to internal and external stakeholders; presented quality budget that included resource planning; developed and optimized processes and procedures that meet global regulatory standards; implemented training, development and career advancement programs; participated in selection, management and oversight of quality contract service providers including CMOs and CROs; dispositioned APIs and finished dosage forms for clinical and commercial use; served as the primary liaison and subject-matter-expert (SME) to the organization as well as U.S. and international agencies for all areas related to quality control and quality assurance. Lead, developed and mentored team members to ensure a cohesive, dedicated and productive quality group.
Skills
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Work History
VICE PRESIDENT, QUALITY ASSURANCE, 2015 to 09/2016
Del Monte Fresh Produce IncForest Park, GA,
  • Implemented phase appropriate Pharmaceutical Quality Management Systems in accordance with applicable elements of ICH Q10 for Sorrento Therapeutics, Inc.
  • Audited Suppliers within US, EU and Asia i.e. France, Italy, South Korea, for GMP compliance during as part of Supplier Evaluation and during Mock Pre-Approval Inspections (PAI)
  • Negotiated and established Quality Agreements with CMOs in accordance with Active Pharmaceutical Ingredients Committee (APIC) and FDA’s Guidance for the Industry “Contract Manufacturing Arrangements for Drugs:  Quality Agreements”
  • Reviewed all GMP documents such as Batch Records, Analytical and QC Micro Data Reports, Validation (IOQ) Protocols/Reports and authorized Product Disposition.  
  • Provided insight to CRO and Contract Labs for OOS investigations performed by CMOs/ Contract Labs to ensure the Root Cause Analysis (RCA) and contributing factors were identified by encouraging the use of Cause and Effect Diagram, 5Why’s, DMAIC and other quality tools as appropriate.  
  • Coordinated all aspects of the QA Program i.e. Change Control, Deviations and CAPAs.   
  • Established Document Control System that included: document hierarchy, document architecture, archival, retrieval and record retention, guidelines for R&D and applicable SOPs to ensure evaluation and management of critical Suppliers, CMO/CRO are built in from development and throughout a product's lifecycle. 
  • Established Employee Training Program.  Trained and coached employees on various GMP topics: such as Good Manufacturing Practices (GMP) for Phase 1 Investigational Drugs, Data integrity-Good Documentation Practices, Lab Notebook Usage & Control, Technical Report Writing.   
  • Worked closely with all departments and successfully coordinated inter-department activities. 
  • Selected, developed, and evaluated personnel to ensure the efficient operation of the function.
  • Assisted in Tech Transfer and CMC activities for Phase III products and introduce new pipe lines of drugs and biologics products to address unmet medical needs.





Senior Director, Quality R&D, 07/2010 to 11/2011
OptivDetroit, MI,
  • Assisted Lachmann Consultants with evaluation of cGMP compliance within Materials Management & Controls as second auditor.
  • Established a cGMP compliant Quality Program within R&D.  Strengthened quality culture and awareness within R&D, implemented the development of strategic plans using a team approach, advised third party contract facilities with documentation and quality requirements, assisted Process Sciences implement procedures for technology transfer and process improvements; coached and focused on improvement for “right the first time”.
  • Eliminated barriers and facilitated proactively investigating quality issues using appropriate process improvement, risk analysis and problem-solving techniques within R&D.  
  • Led a team of Teva auditors evaluate cGMP compliance within the R&D Analytical and assess gaps.  
  • Managed Contract Labs and consultants during WL remediation activities for R&D to ensure Method Validation and Data Integrity (ALCOA) issues are addressed.
  • Co-chaired Global Steering Committee and Local Steering Committee Meetings for Quality Metrics Reporting. 
  • Established protocols and checklists for PAI readiness program that included execution of audit trail checks and 21 CFR Part 11 Compliance checks of HPLC and other R&D lab instruments used for GMP work. 
  • Trained R&D & Quality R&D to perform Quality Metrics Reporting for R&D Quality Councils.   
  • Implemented procedures in R&D to ensure compliance with applicable stage appropriate cGMPs, essential elements of ICH Q8, Q9 and Q10 to ensure pipeline products meet pre-approved acceptance criteria of identity, purity, potency, safety and quality.  
  • Harmonized LABINV-OOS, Deviation Reporting and CAPA Tracking within R&D using Track-Wise.  Trained employees to perform investigations using Quality Tools such as Ishikawa Diagram or Cause and Effect Diagram.  Established procedures for R&D for Root Cause Analysis for quality problems, and prioritize CAPAs using a risk-based approach, resulting in successful Independent Third Party Audits for the R&D Lab.  
  • Improvement in Quality Metrics for R&D with no overdue Deviation Reports, Lab Investigations, FDA Commitments, Training, and CAPAs after implementation of Quality Program in R&D. Quality R&D Protocols and Procedures shared with other Teva R&D Sites.

Senior Director, QA, 08/2014 to 2015
University Of IdahoMoscow, ID,
  • As part of the leadership team, participated in the company's global strategy as relates to quality and quality initiatives.
  • Developed and executed short- and long-term strategies and objectives for the quality function, refined and realigned based on Tolmar's priorities, as needed Improved communication within the department and company-wide; provided training workshops for Good Documentation Practices for quality control (QC), quality assurance (QA), manufacturing, facilities and R&D personnel.
  • Improved, harmonized and facilitated completion of OOS investigations and deviations using Cause and Effect Diagram, 5 Why's, DMAIC and other problem-solving tools. Implemented templates for Failure Investigation Reports to ensure accurate, precise and complete documentation of investigations. 
  • Provided insight to ensure CAPAs are prioritized using a risk-based approach; CAPAs are effective to ensure Root Cause and contributing factors of the problem, are addressed in a timely manner.
  • Reviewed, approved, rejected GXP documents for regulatory submissions such as QbD Reports, Process Development Reports and other cGMP documents.
  • Instituted awareness of QbDs for R&D by working closely with R&D team members, stream-lined procedures to reduce waste by working with cross functional teams; 
  • Trained personnel on data integrity and Good Documentation Practices to ensure raw data recorded for manufacturing, testing, packaging, holding and distribution of drug substances (API) and drug products was Attributable, Legible, Contemporaneous, Original and Accurate.
  • Provided Training Workshops for existing open investigations to ensure Quality Tools such as Cause & Effect Diagram, 5 Why's and Is/ Is Not are used correctly and are meaningful. 
  • Provided hands-on training to Quality Engineers for Risk Assessment using FMEA, Tracking & Trending Key Quality Indicators (KQI) for Management Review Meetings and Annual Employee Meetings.
  • Participated in daily and weekly inter-departmental project meetings to ensure better communication from QA Management, smoother work-flow and prevention of any delays from QA.
  • Reduced cycle time of Batch Record Reviews, to ensure timely release and shipment of product by streamlining work activities in accordance with company priorities; provided hands-on assistance to team members, as needed, assisted QA team during third party /partner audits.



Senior Director, 04/2014 to 07/2014
Aetna Inc.Bayonne, NJ,
  • Established periodic Preventive Maintenance, Calibration, facility decontamination, and cleaning procedures.
  • Trained R&D scientists on Good Documentation Practices, Data Integrity, Lab Notebook Usage and Controls and Writing Technical Reports for Research Projects.



Director, 11/2013 to 01/2014
OptivFresno, CA,
  • As Novartis decided to consolidate its US-EU R&D sites, the BDU was getting ready to close.  Assisted other Novartis Business Units (EBEWE-Sandoz in Austria) for Global Quality Audits and Regulatory Agency Inspections; performed evaluation of Quality Manual and Quality Directives Implementation, provided technical support remotely and on-site with SOP writing, QA reviews, and other quality related documentation requirements.



Head of Development Quality, 05/2012 to 10/2013
OptivIndianapolis, IN,
  • A Novartis Company Head of Dev.
  • Quality Services Unterach, Austria Improved and harmonized applicable phase appropriate cGMP requirements to ensure Quality in Development by the implementation of Quality Program in accordance with Quality Manual, GOPs and key elements of ICH Q8, Q9, and Q10.
  • Strengthened quality culture and awareness within R&D, using a team approach, advise third party contract facilities (CMOs & CROs) to ensure data integrity for source documentation according to Good Documentation Practices; coached Product Development, Analytical Development for "right the first time" concept for process transfers and validations, by implementing written instructions, guidelines, SOPs, protocols, documentation review checklists, file compliance procedures of regulatory submissions and Launch Readiness Checklists as a minimum requirement.
  • Facilitated proactively investigating quality events, deviations, OOSs, OOE, OOT results using appropriate risk-based approach, problem-solving techniques and moved hybrid systems (paper and electronic systems tracking) to Track Wise within Sandoz Development Center resulting in zero overdue Change Controls, CAPAs, Deviations, OOSs, Stability Studies, for Sandoz Development Center at Unterach six months in a row.
  • Assisted Site Tech Ops as a reviewer and provided support during FDA and Global Quality Audits at the Unterach Site.
  • Instituted awareness in cGMPs Compliance for R&D Lab Personnel, provided training and preparation for FDA Inspections, Trained & Certified R&D personnel for Deviation Investigations, Root Cause Analysis and Effective CAPA documentation resulting in improved quality metrics of Key Quality Indicators for CAPAs, Deviations, OOSs, Stability Studies, Trainings for Sandoz Development Center at Unterach and zero critical or major observations from Development at the Unterach site.
  • Established partnership with suppliers for development & co-development contracted work, ensure Supplier Evaluation, Management and Quality oversight of CMOs/CROs (i.e.CAPAs, adequately performed and well written contributing factors and root cause analysis of investigations, Checklists for Batch Record Reviews, etc.) establishment of Quality Agreements; coordinated and assisted with preparation of cGMP compliance regulatory inspections from AGES for CMOs resulting in GMP Certification of CMO manufacturing site.


Quality Consultant-Consent Decree Specialist, 2012 to 04/2012
CarestreamVa, VA,
  • Consent Decree Specialist assigned technical writing responsibilities for Change Control and Document Control.
  • Worked with assigned teams to define, document and implement a compliant, operational, and sustainable quality system. 
  • Streamlined existing SOPs to ensure procedures were user-friendly for the end user of the document.  Added decision trees, "If This/ Then This" tables to assist with decision making.  Added process flow diagrams to help users clearly understand process steps and reduce redundancy.  
  • Reviewed audit reports and corporate quality policies to identify gaps, and propose remediation activities to Group Lead to ensure nonconformities are removed and procedures are followed as written.
  • Assisted in the development of the solutions required to address identified deficiencies; proposed and assisted in the resolution of issues to ensure timelines are not compromised.
  • Actively participated in the deliberations of assigned team; constructively contributed to the team’s charter.  Completed assigned tasks on schedule thereby preventing any penalty for missing proposed timelines.  

Quality Consultant, Current to Current
Johnson MattheyAudubon, PA,
  • Genzyme Allston Landing Facility.
  • Advising on Quality improvements for Change Control, Knowledge Management, Document Architecture, improved various Standard Operating Procedures and structured Site Specific Quality Manual for compliance, operational verification and sustainability.
  • Worked with assigned teams to define, document and implement a compliant, operational, and sustainable quality system.
  • Reviewed audit reports and corporate quality policies to identify gaps, and propose remediation activities to address gaps and ensure compliance.
  • Assisted in the development of the solutions required to address identified deficiencies; assisted in the implementation of these solutions as required.Actively participated in the deliberations of assigned team; constructively contributed to the team's charter.
  • Identified and proposed resolution for issues that may affect the timeline for remediation activities for clients; Completed assigned tasks on schedule thereby preventing any penalty for missing proposed timelines.SME for functional area of responsibility, i.e.Change Control, Document Control, Technical Writing.
Consent Decree Specialist, 08/2010 to 12/2011
Hyatt Hotels Corp., ,
  • Genzyme Allston Landing Facility.
  • Advising on Quality improvements for Change Control, Knowledge Management, Document Architecture, improved various Standard Operating Procedures and structured Site Specific Quality Manual for compliance, operational verification and sustainability.
  • Worked with assigned teams to define, document and implement a compliant, operational, and sustainable quality system.
  • Reviewed audit reports and corporate quality policies to identify gaps, and propose remediation activities to address gaps and ensure compliance.
  • Assisted in the development of the solutions required to address identified deficiencies; assisted in the implementation of these solutions as required.
  • Actively participated in the deliberations of assigned team; constructively contributed to the team's charter.
  • Identified and proposed resolution for issues that may affect the timeline for remediation activities for clients; Completed assigned tasks on schedule thereby preventing any penalty for missing proposed timelines.
  • SME for functional area of responsibility, i.e.
  • Change Control, Document Control, Technical Writing.
Senior Director, 05/1997 to 08/2010
Hyatt Hotels Corp.Breckenridge, CO,
  • Quality R&D Established a cGMP compliant Quality Program within R&D.
  • Improved and harmonized R&D cGMP Compliance Systems.
  • Strengthened quality culture and awareness within R&D, implemented the development of strategic plans using a team approach, advised third party contract facilities with documentation and quality requirements, assisted process sciences implement procedures for technology transfer and process improvements; coached and focused on improvement for "right the first time".
  • Eliminated barriers and facilitated proactively investigating quality issues using appropriate process improvement, risk analysis and problem solving techniques within R&D.
  • Led the preparation and management of external and third party contactor cGMP inspections for the R&D analytical lab.
  • Managed Contract Labs, service providers and consultants during R&D remediation activities for lifting Warning Letter, completing FDA commitments, quality improvement and cGMP compliance.
  • Co-chaired Global Steering Committee and Local Steering Committee Meetings for Quality Metrics Reporting.
  • Established protocols and checklists for PAI readiness program that included execution of audit trail checks and 21 CFR Part 11 Compliance checks of lab instruments used for GMP work within R&D.
  • Trained R&D & Quality R&D to perform Quality Metrics Reporting for R&D Quality Councils.
  • Implemented procedures in R&D to ensure compliance with applicable stage appropriate cGMPs, essential elements of ICH Q8, Q9 and Q10 to ensure pipeline products meet pre-approved acceptance criteria of identity, purity, potency, safety and quality.
  • Trained employees to perform and document investigations using Quality Tools such as Ishikawa Diagram or Cause and Effect Diagram.
  • Established procedures for R&D that includes: Proper documentation of Root Cause Analysis for Deviations, LABINVs, OOSs, CAPAs and SOPs for Review of Controlled Documents and Raw Data, resulting in successful Independent Third Party Audits for the R&D Lab.
  • Demonstrated Improvement in Quality Metrics for R&D with no overdue Deviation Reports, Lab Investigations, FDA Commitments, Training, and CAPAs after implementation of Quality Program in R&D.
  • Quality R&D Protocols and Procedures shared with other Teva R&D Sites.
Senior Director, to
Columbia UniversityNew York, NY,
  • Peregrine Pharmaceuticals develops drugs for treatment of cancer and serious viral infections.
  • Acquired technical depth and broad experience in quality assurance standards, regulatory compliance, and manufacturing of clinical-trial drugs and biologics for oncology and viral infections.
QC Inspector, 01/1997 to
University Of Idaho, ,
QC Chemist/ Lead, 01/1998 to
, ,
QC Supervisor, 01/1999 to
, ,
Manager, 01/2001 to
, ,
Manager, 01/2002 to
, ,
Associate Director, 01/2005 to
, ,
Director, 01/2006 to
, ,
Senior Director, 01/2009 to
, ,
  • Lead the development, maintenance and rolling review of the site compliance systems to support business continuity.
  • Implemented quality action plans at the site and third parties to minimize business risks.
  • Ensured that Standard Operating Procedures are in place and that compliance with cGMP is maintained through internal audits.
  • Monitored and evaluated the level of cGMP compliance for products manufactured, packaged, tested and released at local and regional (delegated) third parties.
  • Continuously improved and harmonized site Quality & Compliance Systems.
  • Strengthened quality culture and awareness, implemented the development of strategic plans, supported third party contract facilities, client contract operations, technical services, and process improvements.
  • Facilitated proactive investigations of quality problems, using rrisk based approach and problem solving techniques.
  • Ensured that the site compliance activities operate in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best quality and cGMP compliance practices.
  • Established and organized a robust Quality System.
  • Management notified immediately of any critical or major quality issues.
  • Established procedures compliant with phase appropriate cGMP regulations such as 21CFR210-211 and ICH Q7 for manufacture, processing, testing, packaging, holding, labeling and labeling, and shipment of clinical drug substance and drug products and commercial product API batches.
  • Products released by QA met pre-approved acceptance criteria of identity, purity, potency, safety and quality required for lot disposition thereby achieved zero product complaints, zero recalls, zero field alerts, zero product withdrawals and zero warning letters over 13.5 year period (1997-2010).
Ink Chemist, 01/1995 to 01/1997
OptivCity, STATE,
  • Continually improved existing ink formulas - analyzed issues and recommend improvements.
  • Planned and executed experiments to check ballpoint ink aging and stability in both plastic and brass refills.
  • Performed QC testing.
Independent Contractor, 01/1993 to 01/1997
Hp IncCity, STATE,
  • Prepared syllabus and assessment for High School Chemistry for State of CA and nation-wide.
Chemistry Teacher, 01/1986 to 01/1987
Amphitheater Public SchoolsCity, STATE,
  • Developed syllabus for High School Chemistry for Torah High School.
  • Taught Chemistry to High School students.
Karachi, Pakistan Chemistry Teacher, 01/1985 to 01/1986
NA, ,
  • Taught Chemistry to High School students.
  • Prepared students for matriculation board exams.
Affiliations
Parenteral Drugs Association (PDA) Regulatory Affairs Professionals Society (RAPS) San Diego Regulatory Affairs Network (SDRAN) American Society for Quality (ASQ) Orange County Regulatory Affairs (OCRA)
Education
Master of Science: , Expected in 1984
University of Karachi - ,
GPA:
Physical Chemistry
Bachelor of Science: Chemistry, Microbiology, Zoology, Expected in 1982
St. Joseph's College - ,
GPA:
Chemistry, Microbiology, and Zoology
Certificate of Mathematics: , Expected in 1985
University of Karachi - ,
GPA:
Certificate : US Regulatory Affairs Certificate, Expected in 2014
RAPS Online University - ,
GPA:
CERTIFICATES AND SEMINARS Certified Quality Manager Preparation Course: , Expected in 1999
ASQ Series) Irvine Valley College - California,
GPA:
Certified Quality Manager Preparation Course ASQ Orange Empire Section (0701),: , Expected in 2004
- ,
GPA:
Process Based Auditing ASQ Orange Empire Section (0701) Mr. Dennis R Arter,: , Expected in 2004
- ,
GPA:
FDA Guidance to Aseptic Processing Southern California Chapter of PDA Jim Akers, James Agallaco,: , Expected in 2004
- ,
GPA:
Introduction to Process Validation ASQ Orange Empire Section (0701) Ms. Linda Garetz,: , Expected in 2004
- ,
GPA:
Pre-Approval Inspections Southern California Chapter of PDA Ms. Caryn McNabb: , Expected in 2003
- ,
GPA:
Media Fills Southern California Chapter of PDA Mr. Jeff Yuen,: , Expected in 2003
- ,
GPA:
Quality & Regulatory Compliance in Biologics and Drugs Shiba Associates, Mr. Ajit Simh,: , Expected in 2003
- ,
GPA:
Deviation, Effective CAPA Reporting & Train The Trainer Certification by Novartis DBA-NSF,: , Expected in 2012
- ,
GPA:
Techniques of Risk Management: , Expected in 2011
ProGamma Science Corporation - ,
GPA:
Problem Solving & Decision Making for CAPA (Kepner-Tregoe),: , Expected in 2011
- ,
GPA:
Quality by Design Teva Parenteral Medicines,: , Expected in 2011
- ,
GPA:
FDA-OCRA Annual Conferences Regulatory Compliance Topics, 2006-2010 OCRA Risk Assessment & Risk Management,: , Expected in 2010
- ,
GPA:
RAC Preparation Course, OCRA,: , Expected in 2009
- ,
GPA:
Annual AOAC-FDA Seminars Various Topics on Quality and Compliance 2006, 2007, 2008 Corrective Actions/Preventive Actions OCRA CAPA Conference 2008, 2010 ASQ Orange Empire Section (0701) CAPA Seminar by Mr. Jack Dhuwalia : , Expected in 2003
- ,
GPA:
US Regulations in Biologics Quintiles, Elizabeth Gorden, Ph.D.
Languages
English- Read, Write & Speak Punjabi- Speak & Understand Urdu- Read, Write & Speak Hindi- Speak & Understand Arabic- Read & Write

By clicking Build Your Own Now, you agree to our Terms of Use and Privacy Policy

Disclaimer
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

How this resume score could be improved?

Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:

56Fair

Resume Strength

  • Length
  • Personalization
  • Target Job

Resume Overview

School Attended
  • University of Karachi
  • St. Joseph's College
  • University of Karachi
  • RAPS Online University
  • ASQ Series) Irvine Valley College
  • ProGamma Science Corporation
Job Titles Held:
  • VICE PRESIDENT, QUALITY ASSURANCE
  • Senior Director, Quality R&D
  • Senior Director, QA
  • Senior Director
  • Director
  • Head of Development Quality
  • Quality Consultant-Consent Decree Specialist
  • Quality Consultant
  • Consent Decree Specialist
  • Senior Director
  • Senior Director
  • QC Inspector
  • QC Chemist/ Lead
  • QC Supervisor
  • Manager
  • Manager
  • Associate Director
  • Director
  • Senior Director
  • Ink Chemist
  • Independent Contractor
  • Chemistry Teacher
  • Karachi, Pakistan Chemistry Teacher
Degrees
  • Master of Science
  • Bachelor of Science
  • Certificate of Mathematics
  • Certificate
  • CERTIFICATES AND SEMINARS Certified Quality Manager Preparation Course
  • Certified Quality Manager Preparation Course ASQ Orange Empire Section (0701),
  • Process Based Auditing ASQ Orange Empire Section (0701) Mr. Dennis R Arter,
  • FDA Guidance to Aseptic Processing Southern California Chapter of PDA Jim Akers, James Agallaco,
  • Introduction to Process Validation ASQ Orange Empire Section (0701) Ms. Linda Garetz,
  • Pre-Approval Inspections Southern California Chapter of PDA Ms. Caryn McNabb
  • Media Fills Southern California Chapter of PDA Mr. Jeff Yuen,
  • Quality & Regulatory Compliance in Biologics and Drugs Shiba Associates, Mr. Ajit Simh,
  • Deviation, Effective CAPA Reporting & Train The Trainer Certification by Novartis DBA-NSF,
  • Techniques of Risk Management
  • Problem Solving & Decision Making for CAPA (Kepner-Tregoe),
  • Quality by Design Teva Parenteral Medicines,
  • FDA-OCRA Annual Conferences Regulatory Compliance Topics, 2006-2010 OCRA Risk Assessment & Risk Management,
  • RAC Preparation Course, OCRA,
  • Annual AOAC-FDA Seminars Various Topics on Quality and Compliance 2006, 2007, 2008 Corrective Actions/Preventive Actions OCRA CAPA Conference 2008, 2010 ASQ Orange Empire Section (0701) CAPA Seminar by Mr. Jack Dhuwalia