Manager, GMP Quality Assurance

Job Duties

• Supervise daily QA work, assign priorities, review completion, train staff, and provide practical guidance on cGMP documentation and quality-system requirements
• Review executed batch records, laboratory records, equipment and cleaning records, logbooks, labels, and supporting documentation for completeness and compliance
• Manage or support deviations, investigations, CAPAs, change controls, nonconformances, complaints, and effectiveness checks; ensure actions are documented and completed on time
• Coordinate document control, SOP issuance, periodic review, archival, forms, templates, and controlled-copy practices
• Support employee training assignments, completion tracking, qualification records, and documentation of GMP readiness
• Partner with Manufacturing, QC, Materials, Facilities, Validation, Regulatory, and management to resolve quality issues and prevent avoidable delays
• Provide QA review and approval of validation plans, risk assessments, protocols, reports, and qualification documentation for facilities, utilities, equipment, processes, cleaning, analytical methods, and software systems
• Work with system owners to maintain a practical validation assessment plan and address gaps in current or legacy validation documentation using documented risk-based decisions
• Support supplier qualification, material-status decisions, quality agreements, vendor documentation, and supplier corrective actions as assigned
• Manage or support customer-complaint investigations and approved recall or product-withdrawal procedures, including documentation, reconciliation, and authorized notifications
• Conduct or coordinate internal audits, floor observations, documentation reviews, and follow-up of findings
• Prepare QA records and subject-matter experts for customer audits and regulatory inspections; track requests, responses, observations, and commitments
• Monitor practical QA metrics such as overdue investigations, CAPAs, change controls, document reviews, training, batch-record review, and recurring documentation errors
• Escalate product-quality, patient-safety, data-integrity, compliance, and release risks promptly to authorized Quality leadership
• Improve QA workflows, templates, training, and quality-system usability without transferring QC laboratory or Manufacturing ownership into QA

Requirements

• Bachelor's degree in life sciences, chemistry, engineering, pharmacy, or a related field, or equivalent relevant experience
• 5+ years of Quality Assurance or closely related cGMP experience in pharmaceutical, biotechnology, peptide, API, sterile, medical-device, or other regulated manufacturing
• 2+ years of supervisory, lead, or functional-management experience, including work assignment, training, review, and employee development
• Hands-on experience with deviations, CAPAs, change controls, document control, training, batch-record review, audits, and inspection readiness
• Working knowledge of cGMP documentation, data integrity, traceability, quality risk, and cross-functional escalation
• Working knowledge of applicable FDA and ICH expectations and risk-based validation practices
• Strong judgment, written communication, investigation, organization, and follow-through skills

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
• Disability insurance 50% standard employer paid
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities