Manager, GMP Quality Assurance

CSBio•Milpitas, CA

About The Position

CSBio is seeking a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing, laboratory operations, materials, documentation, and cGMP compliance. The role manages QA staff and directly supports document review, deviations, CAPAs, change controls, training, batch-record review, audits, and inspection readiness. The manager partners with cross-functional teams to resolve quality issues, supports risk-based validation and supplier qualification, and helps prepare for customer audits and regulatory inspections. The role also monitors practical QA metrics, promptly escalates product-quality and compliance risks to authorized Quality leadership, and improves QA workflows and quality-system usability while keeping QC laboratory and Manufacturing ownership with those functions.

Requirements

Bachelor’s degree in life sciences, chemistry, engineering, pharmacy, or a related field, or equivalent relevant experience.
At least 5 years of Quality Assurance or closely related cGMP experience in pharmaceutical, biotechnology, peptide, API, sterile, medical-device, or other regulated manufacturing.
At least 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.

Responsibilities

Supervise daily QA work, assign priorities, review completion, train staff, and provide 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, including 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 QA metrics, including overdue investigations, CAPAs, change controls, document reviews, training, batch-record review, and recurring documentation errors.
Promptly escalate product-quality, patient-safety, data-integrity, compliance, and release risks to authorized Quality leadership.
Improve QA workflows, templates, training, and quality-system usability without transferring QC laboratory or Manufacturing ownership into QA.

Benefits

Medical, dental, and vision insurance.
Company-paid basic life insurance of $20,000, with optional supplemental life insurance.
Disability insurance with 50% standard employer-paid coverage.
401(k) with a 10% 1:1 match.
10 days of PTO.
Companywide paid holidays during the week of July 4, two days at Thanksgiving, and the 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.