About the role

AI summarised

The QA Manager, External Supply Quality oversees quality assurance for externally manufactured products at a pharmaceutical or biotech company. This role manages supplier quality programs, conducts audits, and ensures compliance with GMP and regulatory standards.

BiotechFull-timeQuality

Key Responsibilities

Manage quality oversight of external manufacturing partners to ensure compliance with GMP and regulatory requirements.
Conduct and lead quality audits of external suppliers and contract manufacturers.
Review and approve quality agreements, deviations, investigations, and change controls.
Collaborate with internal teams to resolve quality issues and drive continuous improvement.
Monitor supplier performance metrics and escalate quality risks.
Support regulatory inspections and customer audits related to external supply.
Ensure timely disposition of materials and products from external sources.

Requirements

Bachelor's degree in Chemistry, Biology, Pharmacy, Chemical Engineering, or related field.
Minimum 8 years of experience in quality assurance within pharmaceutical or biotech industry.
Strong knowledge of GMP, FDA, and international regulatory requirements.
Experience with supplier quality management and auditing.
Proven ability to lead root cause investigations and implement CAPAs.
Excellent communication and cross-functional collaboration skills.
Ability to travel up to 25% for supplier audits.
Certification in quality (e.g., CQA, ASQ) preferred.