System One Associate Director, Quality Validation in Boston, Massachusetts
Title: Associate Director, Quality Validation
Location: 100% REMOTE
Schedule: Standard business hours
Start date: ASAP !
Provide Quality oversight (review and approve) for validation PPQ programs and strategies for both internal and external programs, including audit support/presentation and regulatory document review/approval.
Collaborate with partners in the development of validation protocols for facility, equipment qualification, cleaning/sterilization, and biological PPQ processes.
Support of facility/equipment (internal), PV/PPQ, CSV qualifications/reports including amendments, CAPAs/deviations, risk assessments, and Data Integrity evaluations.
Provide Quality Validation oversight and strategies for internal/external deviations and assessments for change controls.
Investigate and approve exceptional conditions during the execution of protocols, as well as, other atypical events, deviations, OOS and non-conformances as required.
Collaborate with and mentor both internal and external partners on our client's quality systems and validation requirements.
Identify and support continuous improvements projects related to QA and validation.
Participate and approve risk assessments for both internal and external partners.
BS/BA degree with 10+ years of pharmaceutical industry experience.
Five+ years management / team lead experience.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including biologic DS/DP process validation.
Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (FDA CFR Sections 210, 211, 610, 820 and Eudralex Vol 4; and related guidances, including PDA, ISO and ICH)
Expertise in quality systems, qualification / validation of facilities, equipment, processes (including cleaning/sterilization and biological PPQ) and CSV.
Participation with internal and external audit support/presentations and regulatory document review/approval.
Excellent verbal & written communication along multiple disciplines, along with negotiating skills.
Successful record of cross-functional collaboration across multiple disciplines.
Excellent influence and decision-making abilities.
Demonstrated flexibility and agility in a rapidly changing environment.
Expert-level of technical experience in validation, including equipment, cleaning/sterilization validation, biological process validation, and computer system validation.
Direct Global Regulatory agency/partner inspection experience.
Strong technical expertise with data integrity and risk management principles.
Foundational understanding of statistical tools and analysis.
Experience working with prefilled syringes.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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