Associate Director, QA Operations
Key Responsibilities
- Lead QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
- Oversee technical documentation for batch disposition (e.g. batch record reviews, CoAs, deviation/OOS investigation reports, stability data) to support in-market product release.
- Ensure quality processes align with international standards and local market requirements.
- Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
- Oversee Quality Management System for assigned vendors: deviation investigation, CAPAs, change control management, product quality reviews (PQRs), compliance risk assessment, self-inspections, and Quality Technical Agreements.
- Support inspections from the local Health Authorities and follow-up actions
- Conduct GMP/GDP audits of CMOs, 3PLs, and other vendors.
- Participate in local risk management and escalation processes aligned with global procedures.
- Lead continuous improvement and training of QA personnel related to regulatory/compliance requirements.
- Lead a team of QA Operations personnel.
Required Skills and Experience
- Minimum 10 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
- Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
- Team management experience.
- Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.
Preferred Qualifications
- Degree in pharmacy, chemistry, or biology or any other related science background.
