Associate Director, Quality Operations - Permanent - Hybrid
Proclinical Staffing is seeking an Associate Director, Quality Operations to join a cutting-edge biotech company. This is a permanent role with the opportunity to work hybrid. This position is based in Redwood City, CA with a 3-day onsite expectation.
Primary Responsibilities
This position will collaborate with CMC, Regulatory Affairs, Clinical Operations, and Quality Systems to provide support and oversight to manufacturing and testing (clinical and commercial) sites to ensure that products are produced and tested in compliance with applicable regulations, legislation, guidelines, and company requirements.
Skills & Requirements:
- BA/BS degree with a minimum of 12 years' experience in the pharmaceutical industry (oral solid dose preferred), including at least 8 years in a quality assurance operations role.
- Thorough knowledge and understanding of cGMP and relevant (EU and US) regulations, legislation, and pharmaceutical manufacturing industry standards for pharmaceutical manufacturing.
- Superior communication skills (both written and oral) are essential. Demonstrated ability to contribute successfully in a multi-disciplinary team environment.
- Demonstrated ability to successfully work with and influence contract manufacturing/testing partners while maintaining a positive working relationship.
- Working knowledge of health authority inspections and inspection readiness activities.
- Experience coordinating and conducting audits of CMOs and CTLs.
- 10% travel is expected.
The Associate Director, Quality Operations will:
- Provide quality direction and oversight of third-party manufacturing activities, ensuring compliance with cGMP, regulatory requirements and quality standards.
- Responsible for the lot review and disposition of all commercial and clinical products produced at third-party contract manufacturing organizations.
- Review and approve contractor master batch records, executed batch records, deviations, change controls and validations.
- Lead and support investigations into manufacturing discrepancies, deviations, and non-conformities, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs).
- Assess the impact of proposed changes on product quality requirements.
- Assist with the management of the supplier quality program including performance of external supplier audits, risk ranking, supplier qualification and remediation. May assist in drafting and negotiating Quality Agreements.
- Responsible for the collection and presentation of quality metrics related to the quality oversight activities.
- Collaborate cross-functionally with CMC, Regulatory Affairs, and other departments to facilitate effective communication and resolution of quality-related issues.
- Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement.
- Report and escalate significant quality observations/risks to Quality Management.
Salary / Pay:
Ranges from $170,000 - $220,000 per year depending on experience
If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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