A global biopharmaceutical company is seeking a detail-oriented and experienced Quality Assurance Maanger to oversee product and vendor management for both their sterile and non-sterile drug products and APIs. This role supports the full product lifecycle in a virtual manufacturing environment, ensuring compliance with regulatory standards and internal quality systems. The position involves managing contract manufacturers, packagers, testing laboratories, raw material suppliers, and distribution partners for both commercial and clinical products.
Key Responsibilities:Quality Assurance & CMC Oversight- Manage external partners involved in manufacturing, packaging, testing, and distribution from raw materials to finished goods.
- Oversee contract testing organizations, including budget planning and purchase request submissions.
- Review and approve Certificates of Analysis, batch records, testing records, and product specifications.
- Evaluate and approve deviations, out-of-specification (OOS) results, and customer complaint investigations, including associated CAPAs.
- Review and approve change controls related to manufacturing, testing, and other quality-impacting processes.
- Approve validation and qualification protocols and reports for manufacturing, packaging, test methods, equipment, and facilities.
- Ensure timely disposition of API, intermediates, and finished drug products.
Documentation & Compliance- Author and review SOPs, specifications, and work instructions to ensure alignment with GMP and regulatory requirements.
- Conduct investigations and write reports for procedural deviations.
- Manage and maintain the stability program and reference standards.
- Perform trend analysis on stability and lot release data as needed.
- Conduct risk assessments for non-conformances and change controls impacting product quality.
- Prepare and maintain Annual Product Reviews (APRs) and monthly quality metrics.
Vendor & Partner Collaboration- Manage vendor change controls.
- Draft, revise, and maintain Quality Agreements.
- Provide technical support to marketing partners and assist with client and regulatory audits.
- Participate in audits of contracted facilities as needed.
Key Qualifications:- Bachelor's Degree in a Scientific related field.
- Minimum of 5 years of QA experience in the pharma/biopharma industry/
- Sterile quality experience is a must.
- CRO experience and ASQ Certification are highly preferred.
- Strong understanding of Annex 1 is preferred.
