Senior GMP QA Manager – Peptide Manufacturing

Yowei Therapeutics; Milpitas (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Holiday pay

Job summary

Yowei Therapeutics seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing, documentation, and cGMP compliance. You will lead QA staff, review batch records, manage deviations and CAPAs, and ensure timely closure with cross-functional teams.

You will coordinate document control, SOPs, training, and GMP readiness while collaborating with Manufacturing, QC, Materials, Facilities, and Regulatory to resolve quality issues and sustain inspection

Qualifications

• 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.

Responsibilities

• 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 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 documented risk-based decisions.
• Support supplier qualification, material-status decisions, quality agreements, vendor documentation, and supplier corrective actions as assigned.
• Manage customer-complaint investigations and approved recall 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 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.

Skills

Quality Assurance

cGMP

Documentation

Deviations & CAPAs

Change controls

Audits

Training

Education

Bachelor’s degree in life sciences, chemistry, engineering, pharmacy

Job description

Yowei Therapeutics seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing, documentation, and cGMP compliance. You will lead QA staff, review batch records, manage deviations and CAPAs, and ensure timely closure with cross-functional teams.

You will coordinate document control, SOPs, training, and GMP readiness while collaborating with Manufacturing, QC, Materials, Facilities, and Regulatory to resolve quality issues and sustain inspection