QP&QA Manager
QP&QA Manager
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Job Description
Winid is a talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.
Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people diversity and inclusion innovation and cutting-edge technology.
About the client:
Its a well-established global pharmaceutical development and licensing company that is expanding its operations into the European Union by setting up a dedicated testing and EU release site in Spain. With over 150 finished products licensed to more than 100 partners across EMEA APAC LATAM and North America the company is now investing in local infrastructure to offer direct support to its European B2B partners.
Job description:
This new facility will house a state-of-the-art quality control laboratory focused on oral solid dosage forms. As the Qualified Person & Quality Assurance (QP&QA) Manager youll play a central role in building this project from the ground updeveloping systems interacting with authorities and establishing a new team that will carry forward the companys commitment to quality and compliance.
What Youll Do:
- Define and implement the sites Quality Policy in alignment with GMP and GDP guidelines.
- Establish and maintain a robust inspection-ready Quality Management System (QMS).
- Review and approve key documentation: CoAs SOPs analytical methods product specs and work instructions.
- Evaluate batch documentation for manufacturing and packaging to ensure EU GMP and MA compliance prior to release.
- Investigate and manage deviations OOS/OOT results CAPAs and Change Controls.
- Oversee Quality Agreements with CMOs subcontractors and B2B clients.
- Act as the companys representative in regulatory inspections and client audits.
- Lead the qualification and ongoing oversight of CMOs and third-party suppliers.
- Serve as the primary point of contact for quality-related discussions with manufacturers clients and regulators.
- Recruit build and lead your own Quality and QA team as the site grows and operational needs expand.
Who You Are:
- Degree in Pharmacy and EU-recognized Qualified Person (QP) certification.
- Experienced as a Qualified Person or Deputy QP or a candidate with a Pharmacy degree and at least 5 years in Quality Assurance within the pharmaceutical industry.
- Deep understanding of EU GMP requirements and quality systems.
- Prior experience with oral solid dosage forms is highly desirable.
- Fluent English speaker with excellent written and verbal communication skills.
- A hands-on detail-focused leader with strong problem-solving capabilities.
- Comfortable in a dynamic entrepreneurial setting where you can make things happen.
Why This Role Is Unique:
- Create something meaningful: Be part of designing and certifying a new EU lab and release site.
- High-impact leadership: Set the quality vision and culture while recruiting and developing your own team.
- Global collaboration: Interact directly with international manufacturers clients and regulators.
- Strategic project: High visibility within a stable and globally active pharmaceutical company.
- Professional growth: Competitive compensation autonomy and the opportunity to grow with the business.
Employment Type
Full Time
