Quality Assurance Manager

The CMO Quality Manager ensures full quality oversight of Contract Manufacturing Organizations (CMOs), guaranteeing compliance with Marketing Authorization dossiers, GMP requirements, and company guidelines. The role safeguards product quality, safety, and supply continuity across the product lifecycle, including technology transfers, risk management, audits, and quality system improvement.

Key Responsibilities CMO Oversight & Compliance

Ensure Quality Technical Agreements (QTAs) are in place and maintained.

Oversee GMP compliance, product specifications, and regulatory requirements.

Lead CMO qualification, audits (risk-based), and CAPA follow-up; escape critical findings.

Manage non-conformities, deviations, complaints, and recall coordination when required.

Review and approve Product Quality Reviews (PQRs) and related CAPAs.

Ensure change controls are assessed for quality, regulatory, and supply impact.

Oversee stability programs in line with ICH guidelines.

Prepare and present CMO Quality Management Reviews and KPIs.

Risk & Cross-Functional Collaboration

Conduct risk assessments covering quality, compliance, and supply continuity.

Collaborate closely with Supply, Procurement, Regulatory, Pharmacovigilance, and affiliates.

Support risk mitigation planning and integration of newly acquired CMOs.

Lead quality oversight of tech transfer projects (outsourcing, dual sourcing, cost optimization).

Ensure validation activities (process, cleaning, analytical method transfer) are completed.

Support documentation for regulatory submissions and affiliate filings.

Quality System Development

Contribute to the development and continuous improvement of a global CMO Quality System.

Strengthen processes for qualification, change control, escalation, and complaints management.

Support implementation of electronic document management systems (EDMS).

Qualifications & Experience

5–10 years’ experience in pharmaceutical quality within a manufacturing environment.

Strong CMO/third-party QA oversight experience.

Experience with technology transfers and audits.

Deep knowledge of GMP and global regulatory requirements (FDA, EMA, ICH, ISO).

Proven project management and cross-functional leadership skills.

Core Competencies

Strong problem-solving and risk assessment skills

Collaborative and cross-functional mindset

Proactive, pragmatic, and results-driven

Effective communicator and persuasive stakeholder manager

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