BioSpace · 5 days ago

Sr. Manager, Quality Assurance

San Carlos, CA

Full-time

Onsite

Senior Level

$176K/yr - $190K/yr

8+ years exp

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Comp. & Benefits

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Responsibilities

QA Representative for quality management of analytical activities for Vaxcyte drug products.

Represent QA at internal and external cross-functional team meetings.

Key participant in quality team focused on the oversight of analytical processes and results at CMOs.

Review and approve internal and external documentation for compliance such as analytical methods and their validation protocols and reports, risk assessments, change controls, deviations and CAPAs as they related to QC for Vaxcyte drug products.

Review and approval of specifications and COAs for drug products.

Review and approval of all documentation related to reference standards for drug products.

Establish, review, and periodically update GMP related internal procedures and policies, as needed.

Maintain appropriate development phase MP compliance for analytical testing of drug products.

Support process improvement initiatives.

Interact with key stakeholders to develop solutions to complex issues.

Review and assess temperature excursions.

May participate in compliance audits as required.

Promote a quality mindset and quality excellence approach to all activities.

Qualification

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GMPsFDA RegulationsICH GuidelinesClinical Product KnowledgeCommercial Product KnowledgeContract Manufacturing OrganizationsProblem-SolvingCollaborationCommunicationLeadershipOwnership