Associate Director, Quality & Primary QP
Associate Director, Quality & Primary QP
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Associate Director, Quality & Primary QP
Overview
This is a unique opportunity for a Qualified Person (QP) to step into a leadership role, overseeing quality oversight and batch certification for a diverse portfolio of aseptically manufactured drug products. You’ll bring scientific expertise, strong quality instincts, and a people-first mindset to support both day-to-day operations and strategic projects. The role blends technical leadership, regulatory engagement, and team development in a dynamic, fast-paced environment.
Key Responsibilities
* Serve as the primary QP responsible for batch certification of parenteral products under EU GMP guidelines.
* Provide guidance across quality operations, technical issues, audits, and inspection readiness.
* Lead and develop a team of QPs, offering coaching, mentorship, and problem-solving support.
* Collaborate cross-functionally with stakeholders to support quality systems, product launches, and continuous improvement.
* Act as the quality lead during regulatory inspections and vendor audits.
* Ensure compliance with EU directives for both commercial and investigational products.
* Oversee complaints management, product disposition, and documentation in line with regulatory expectations.
Education & Experience
* Degree in Pharmacy, OR Degree in a science discipline + postgraduate qualification meeting QP eligibility under Directive 2001/83/EC.
* 8+ years in pharmaceutical or biotech manufacturing, including QP responsibilities.
* In-depth knowledge of GMP, GDP, and EU quality regulations.
* Hands-on experience with aseptic drug products, validation, and batch release.
* Strong communication, leadership, and decision-making skills.
* Experience managing inspections, investigations, and cross-functional teams.
Other Information
* Travel may be required for audits or external partner visits.
* This role reports to the Director of Quality and includes people and project management responsibilities.
* Familiarity with sterile manufacturing technologies and product lifecycle support is a plus.
If you’re an experienced QP who’s passionate about quality, loves solving complex challenges, and enjoys leading with purpose we want to hear from you!
Apply today and bring your expertise to a role that truly makes an impact!
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Production
* Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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