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associate director head gmp audit europe middle east africa compliance external collaboration resume example with 17 years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Executive Summary
  • Executive Quality Professional with over 19 years of quality management, supervision, regulatory compliance and interpretation, GXP audits, and manufacturing experience within regulatory focused global environments. Five years of successful expatriate assignment in Switzerland.
  • Established experience in Quality Assurance, Manufacturing, and GXP Audit Organizations of Genentech Inc., USA and F. Hoffmann-La Roche Ltd., Switzerland. Experience includes active pharmaceuticals, medical device, combination product, biotechnology, specialty chemical, packaging components, distributors, warehouses, laboratories, logistic providers, contract manufacturing organizations, sterilization service providers, and pharmaceutical quality system elements.
  • Demonstrated success in establishing GMP audit groups in USA and Europe which are recognized for value added audits: verification of GMP compliance, business effectiveness and efficiency, and promotion of continual improvement.
  • Ability to expand the historic focus of internal audit organizations from value preservation (control focus) to value creation (performance focus). Provides strategic input via audits for risk identification and prioritization, verification of business effectiveness through scrutiny of alignment of people, processes, systems, interfaces and good management practices.
  • Success in managing GMP audit professionals tasked with oversight of more than 250 internal and contract manufacturing organizations around the world. Track record of leading over 100 GMP compliance audits of internal and contract manufacturing facilities around the world.
  • Demonstrated experience in advising management and stakeholders on complex compliance and product quality issues. Effective in working with cross functional teams of any level, in a global environment.
  • Driven to add value and establish strategic, mutually beneficial partnerships and relationships with global internal stakeholders, contract manufacturing organizations and service providers.
  • Ambitious quality director who creates strategic alliances with all internal stakeholders across product life cycle to ensure organizations right to operate.

Skill Highlights
  • Collaborate with functional groups across the globe.
  • Risk management and continual improvement.
  • Outsourcing activities and technology transfer.
  • Develop SOPs & manuals.
  • Provide regulatory input for follow-up to inspections and audits.
  • Assess regulatory/patient impact from quality issues, changes etc.
  • Lead GXP audits around the world.
  • Anticipate issues or obstacles imposed by regulatory requirements and provide solution.
  • Analyze regulatory guidelines, policies to determine regulatory impact.
  • Keep abreast of evolving regulatory requirements and integrate into the organization.
  • Creation of a higher level of risk and control awareness and provide management with objective evaluations and opinions regarding internal controls.
Education and Coursework
Addis Ababa Addis Ababa, Expected in Bachelor of Science : Chemistry - GPA :
, CA/Basel Switzerland Expected in Certifications : Quality and Regulatory - GPA :

Certified Lead Auditor- Pharmaceutical Audits & Self-Inspections

Certificate of Roche Quality Certification Program

Certified Manager of Quality/Organizational Excellence (ASQ)

Certified Pharmaceutical GMP Professional (ASQ)

Quality System Requirements and Industry Practice (AAMI)

Leadership Development Program (Center for Creative Leadership)

Certified Quality Auditor (ASQ)

Core Accomplishments

Project Management:

  • Initiated effective and integrated audit program which resulted in routine audit of Interfaces, scrutiny of business processes, good management practices and resulted in identification of systemic gaps and value added audit. Going beyond simple compliance check.

Human Resources:

  • Spearheaded new Auditor Rotational Program and Employee Exchange Program which increased retention. Resource development and planning.

Operations Management:

  • Managed GXP audit operations tasked with audits of internal and external functions around the globe.
  • Handled all management functions related to GMP audit program.

Staff Development:

  • Helped to launch well-received program of professional development courses for all staff.
  • Mentored and coached employees resulting in a 15% increase in productivity, by delivering expected results with more workload but same number of staff.
Professional Experience
Bkd, Llp - Associate Director, Head GMP Audit Europe Middle East & Africa-Compliance & External Collaboration
Madison, WI, Switzerland 07/2010 - 08/2015
  • Established new Audit Group that is tasked with oversight of over 250 internal and external sites.
  • Recruited, developed, managed and mentored GMP audit professionals.
  • Managed audit program-risk based planning, execution, follow up and evaluation of effectiveness of the program.
  • Led and/or participated in quality issues management program and provide strategic solution.
  • Led critical and systemic audits of internal and external facilities.
  • Developed audit manuals, training materials and SOPs.
  • Participated in developing/updating GMP audit policies.
  • Provided strategic guidance for resource planning & development.
  • Assessed emerging compliance issues throughout product life cycle and developed solutions to them.
  • Developed strategies for complex issues with potential for significant regulatory compliance impact.
Caci International Inc. - Audit Manager/Senior Manager
Stennis Space Center, MS, 03/2009 - 07/2010
  • Manage GMP Systems Compliance audit program and team of Quality professional.
  • Perform resource planning, coaching and training.
  • Review and approve audit reports.
Ockham - Senior Technical Manager
Kansas City, MO, 04/2006 - 03/2009
  • Lead internal and external GXP audits within U.S.A and international.
  • Develop training materials for the GXP Systems Compliance department.
  • Reviewed and approved audit reports and compliance opinions.
  • Manage a cross-functional initiative to achieve better collaborations among internal groups.
  • Presented and defended audit program to regulatory agencies.
Emd Millipore - Senior Supervisor
Norwood, MA, 03/2001 - 04/2006
  • Review and approve deviations and investigations.
  • Oversee a group of 19 QA professionals, with three quality assurance supervisors as direct reports.
  • Initiate, led and interacted with cross functional departments to resolve quality issues.
  • Review and approved electronic change requests, documents and quality investigations.
  • Worked in TrackWise (DMS), LIMS etc.
  • Perform line clearances to support marketed/clinical filling operations.
  • Review batch records.
Genentech Inc - Manufacturing Technician
City, STATE, 08/1998 - 03/2001
  • Execution of various process operations, system preparation and trouble shooting in recovery operations and cell culture productions.
  • Provide On the Job Training (OJT) for new technicians in Recovery operation processes.
Interests

Spending time with family/kids

Running

Entertaining family and friends

Skills
  • International Regulations and Standards (FDA, EMA, MHRA, WHO, ICH etc.), GMP Audits, Mock Inspection, Regulatory, and Compliance
  • Quality Assurance and Manufacturing Operations in Biotechnology, Small Molecule, Medical Devices, and Combination Products.
  • Pharmaceutical Quality Management System, Investigations, CAPA, change control, Risk Management, Lot Release, Validation, and Technology Transfer.
  • Training, coaching and resource planning.
  • Suppliers/vendor management, lot release, technology transfer, validation.

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Resume Overview

School Attended

  • Addis Ababa

Job Titles Held:

  • Associate Director, Head GMP Audit Europe Middle East & Africa-Compliance & External Collaboration
  • Audit Manager/Senior Manager
  • Senior Technical Manager
  • Senior Supervisor
  • Manufacturing Technician

Degrees

  • Bachelor of Science
  • Certifications

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