sr director quality and analytical development resume example with 9+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
:
Professional Summary
Highly motivated Sales Associate with extensive customer service and sales experience. Outgoing sales professional with track record of driving increased sales, improving buying experience and elevating company profile with target market.
Skills
PQS Implementation and Global Quality Systems
Organizational Strategy Development and Execution
Organizational Growth, Leadership, and Staff Development
Quality Risk Management
Regulatory Compliance, PAI Inspection Management, and IND / CMC Support
CQA Certified: Audits performed in multiple industries against multiple regulations (CMOs, Suppliers, Commercial Biologics, etc.)
Manufacturing Operations and Process Technical Transfer
Yellow Belt Certification
PDA Quality Culture training and program implementation
Work History
Sr. Director, Quality and Analytical Development , 05/2021 - Current Novavax Inc. – Gaithersburg, MD,
Provided quality & analytical development oversight and strategic leadership for StrideBio.
Led the quality organization by directing quality activities supporting the start-up of a gene therapy clinical manufacturing and development organization.
Responsible for the development and growth of the quality organization.
Execute business plans and develop tools to facilitate the startup project initiatives and administrative activities.
Set and administered yearly budget for quality, analytical development, quality control, and microbiology.
Led the development, implementation, and administration of all aspects of the pharmaceutical quality system processes.
Provided leadership on quality policies and practices, while working in collaboration with multiple department functions.
Provided quality & compliance oversight and leadership for KBI Biopharma Quality.
Managed operational and compliance teams of upwards of 40 FTE’s and consultants.
Responsible for the buildout of the KBI QA compliance and QA operational functions. Includes restructuring, recruitment, interviewing, hiring, and development of individuals.
Responsibility over all elements of the PQS including internal compliance, self-inspections, inspection readiness, regulatory inspection management, deviations, CAPAs, change controls, batch review, batch disposition, manufacturing quality, QA raw material oversight, and document management.
Successfully managed PAI of the Filgrastim Biosimilar and Dextenza DP testing, including inspection readiness, hosting, and post inspection responses/remediation activities.
Facilitate strategic quality and compliance growth and continuous improvement initiatives Including
Buildout of a comprehensive self-inspection program.
Value mapping and redefinition of deviation/CAPA management programs.
Conversion of paper based LMS to an integrated elm.
Roll out of companywide (multi-site) PDA Quality Culture program.
Development and roll out of a comprehensive Quality Risk Management program.
Senior Quality & Compliance Auditor, 08/2016 - 06/2017 Tolmar Inc. – City, STATE,
Provided quality & compliance expertise and auditing for organization.
Oversight of quality system audits, both internal and external (domestic and international). GMP, GCP, GLP, RD, AD, etc.
Oversight of and responsibility for the development and management of the supplier quality management and material qualification programs.
Oversight of and responsibility for the management of internal compliance.
Sr. Project Manager / Quality Compliance Consultan, 07/2013 - 12/2016 Independent Consultant / Azzur Group – City, STATE,
Provided Consulting services for major pharma / biologics clients including KBI Biopharma, Novavax, Oso Biopharmaceuticals, Shire HGT, Novo Nordisk, Alexion Pharmaceuticals, Bristol Myers Squibb, etc. Managed project teams ranging from 1-10 consultants.
Responsible for developing project proposals and SOW’s.
Responsible for developing teams of consultants for defined projects including recruiting, interviewing, and hiring.
Provided leadership to project teams and works closely with business functions to drive improved operations while managing multiple projects and providing status updates on performance against plan and defined delivery targets.
Development of project plans and models for different continuous improvement and implementation initiatives including PQS/QMS program revisions, developments, and Implementation.
Regulatory inspection preparation and observation remediation SME.
Facilities & Engineering Support including validation review, approval, and remediation.
Education
Master of Science: Strategic Leadership And Management, Expected in 08/2023 - Western Governors University - Salt Lake City, UT GPA: Status -
Bachelor of Science: Healthcare Management , Expected in 08/2022 - Western Governors University - Salt Lake City, UT GPA: Status -
Certification: Biopharmaceutical Manufacturing Training, Expected in 2009 - University of Rhode Island - Kingston, RI GPA: Status -
Certification: Biological Sciences, Expected in 2005 - Chaffey College - Rancho Cucamonga, CA GPA: Status -
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