- Company Name
- Proclinical Staffing
- Job Title
- Director, GMP QA Operations
- Job Description
-
**Job Title:** Director, GMP QA Operations
**Role Summary:**
Leads the Quality Assurance function for GMP compliance across biologics and aseptic manufacturing, ensuring regulatory readiness from early development through commercial launch. Provides strategic direction, oversees quality systems, and drives continuous improvement while managing a cross‑functional QA team.
**Expectations:**
- Maintain FDA cGMP, ICH, and other regulatory compliance.
- Deliver timely review and approval of GMP documentation and change controls.
- Lead internal audits, support regulatory inspections, and ensure effective CAPA implementation.
- Manage third‑party GMP partners and oversee training programs.
- Foster a high‑performing QA team through coaching, development, and performance management.
**Key Responsibilities:**
- Direct QA Operations and supervise the Quality team (coaching, development, performance).
- Approve SOPs, batch records, protocols, specifications, and validation documents.
- Manage deviations, non‑conformances, CAPAs, complaints, and change controls.
- Conduct internal audits, participate in regulatory inspections, and verify corrective actions.
- Oversee GMP training for manufacturing and quality personnel.
- Monitor quality system KPIs, risk management, and escalation of critical issues.
- Provide oversight of third‑party GMP service providers.
- Collaborate with cross‑functional teams to ensure compliant, efficient operations.
- Identify and lead continuous‑improvement initiatives across quality systems.
**Required Skills:**
- Deep knowledge of GMP requirements for biologics/aseptic manufacturing.
- Strong understanding of quality systems, risk management, and regulatory expectations.
- Proven leadership and team‑management experience.
- Excellent communication, problem‑solving, and organizational abilities.
- Ability to manage complex projects and make sound quality/compliance decisions.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree preferred).
- Relevant GMP/QA certifications or training (e.g., ASQ Certified Quality Engineer, Certified GMP Professional) desirable.