Director of Quality Assurance

My client is a leading pharmaceutical Contract Development and Manufacturing Organization (CDMO) partnering with the world's premier pharmaceutical and biotechnology companies to bring life-changing therapies to patients. They specialize in the development and manufacture of high-quality drug products, driven by a passion for innovation and operational excellence.

About the Role

They are seeking an experienced and strategic Director of Quality Assurance, Drug Product to lead their Quality Assurance function and champion a culture of quality and compliance across their drug product manufacturing operations. In this key leadership role, you will be accountable for all QA activities at the production and quality control facilities, ensuring the safety, identity, strength, purity, and quality (SISPQ) of all drug products in accordance with current Good Manufacturing Practices (cGMP). You will serve as the senior quality leader on site, providing strategic direction for quality systems, regulatory compliance, and continuous improvement. This role requires a leader who can build strong partnerships with internal stakeholders, clients, and regulatory bodies to drive quality excellence and support business growth objectives.

Responsibilities

• Strategic Quality Leadership: Establish, implement, and maintain a robust Quality Management System (QMS) that ensures continuous inspection readiness and compliance with global regulatory standards (FDA, EMA, Health Canada).
• Drug Product Disposition: Direct the timely and compliant disposition of all raw materials, packaging components, and finished drug products, including overseeing the resolution of investigations and deviations.
• Operational Oversight: Provide QA oversight for manufacturing, packaging, laboratory, and warehouse operations. Lead the Quality presence on the production floor to proactively identify and mitigate risks.
• Regulatory & Client Engagement: Lead and facilitate regulatory inspections, internal audits, and customer audits. Act as the primary Quality representative for key client relationships, instilling confidence in quality capabilities.
• Team Development: Build, mentor, and lead a high-performing Quality Assurance team. Foster a culture of accountability, continuous improvement, and professional development.
• Quality Systems Management: Oversee critical quality systems, including deviation management, CAPA, change control, and validation programs. Drive the use of key performance indicators (KPIs) to measure and improve quality performance.

Requirements

• Bachelor of Science (BSc) degree in a Scientific or Engineering discipline (e.g., Chemistry, Biology, Pharmacy, Chemical Engineering).
• Minimum of 10 years of experience in Quality Assurance or Compliance within the pharmaceutical or biotechnology industry.
• Minimum of 8 years in a supervisory or management role.
• Deep understanding of GMP regulations and quality operations in a drug product manufacturing environment. Experience in a CDMO setting is highly preferred.
• Strong working knowledge of global regulatory requirements, including FDA 21 CFR Parts 210/211, EU GMP, and ICH guidelines.
• Proven ability to lead, motivate, and develop diverse teams. Strong decision-making skills with the ability to balance compliance and business needs.