Senior cGMP QA Manager – Peptide Manufacturing

CSBio; Milpitas (CA); Vor Ort; USD 110.000 - 165.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401k with 1:1 match

Paid time off (PTO) 10 days

Company holidays

Life and disability insurance

Reimbursement for carpool / cell phone

Employee recognition program

Team-building activities

Zusammenfassung

CSBio in Milpitas, CA seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing and cGMP compliance. You will manage QA staff, review deviations, CAPAs, change controls, training, batch-record review, audits, and inspection readiness.

The role requires 5+ years in QA within regulated manufacturing, including 2+ years in a supervisory capacity, and strong knowledge of FDA/ICH expectations.

Qualifikationen

• Bachelor's degree in life sciences, chemistry, engineering, pharmacy, or 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.

Aufgaben

• 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 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 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 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 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 Quality leadership.
• Improve QA workflows, templates, training, and quality-system usability.

Kenntnisse

Quality Assurance

cGMP

Document control

Audits

Leadership

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

CSBio in Milpitas, CA seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing and cGMP compliance. You will manage QA staff, review deviations, CAPAs, change controls, training, batch-record review, audits, and inspection readiness.

The role requires 5+ years in QA within regulated manufacturing, including 2+ years in a supervisory capacity, and strong knowledge of FDA/ICH expectations.