Site Quality Head 100% (m/f/d)

The Site Quality Head / Qualified Person (QP) leads the Quality Assurance and Quality Control functions at Birgi Mefar part of ArCera, ensuring all pharmaceutical products are manufactured, tested, and released in compliance with regulatory requirements, ArCera standards, and GMP. This role combines strategic leadership of both QA and QC teams with the statutory duties of the QP, including batch certification and regulatory interface.

Key Responsibilities 

1. Strategic Leadership & Operational Excellence: 

• Demonstrate deep operational experience in pharmaceutical manufacturing, with hands-on knowledge of both QA and QC processes.
• Ensure robust oversight of manufacturing, testing, and distribution, with a focus on aseptic/sterile operations.
• Promote and implement Quality by Design (QbD) principles across all site activities, embedding quality into every stage of product lifecycle.
• Support the implementation of new analytical technologies and continuous improvement in QC.

2. Aseptic Manufacturing: 

• Strong understanding of aseptic processing, cleanroom operations, and contamination control.
• Maintain high standards in sterile/ aseptic manufacturing environments.

3. Qualified Person (QP) Duties: 

• Certify that each batch of medicinal product is manufactured and tested in accordance with Customer’s Marketing Authorization requirements (MA), GMP, and applicable regulations.
• Oversee batch release activities, ensuring all deviations, OOS/OOT, and CAPAs are properly investigated and documented.
• Maintain oversight of the supply chain to prevent distribution of non-compliant or falsified medicines.
• Ensure compliance of third-party manufacturers and suppliers with GMP standards.
• Refuse batch certification in case of severe GMP violations or ethical concerns.
• Maintain up-to-date knowledge of legal requirements and technical standards.

 4. Authorities:

• Certify and release batches of medicinal products.
• Lead and approve CAPA, deviation, and change control processes.
• Represent the site in regulatory inspections and audits.
• Approve hiring and performance management decisions for QA/QC staff.

 5. Compliance & Regulatory Affairs:

• Ensure site operations comply with local, national, and international regulatory requirements (e.g., EU GMP, Turkish MOH, etc.).
• Prepare for and participate in regulatory inspections, responding to findings and implementing corrective actions.
• Lead the development and review of SOPs, validation protocols, and quality documentation.
• Interface with regulatory authorities and Marketing Authorization Holders (MAHs) as required.

6. Talent & Team Development:

• Lead and develop a high-performing the quality team, fostering collaboration across functions and regions.
• Develop talents and foster a growth-mindset.
• Establish Quality & Data integrity culture and awareness.
• Establish capability-building and upskilling programs to enhance current quality departments.

7. Inspection & Audit Readiness: 

• Ensure the site is always inspection-ready for internal, external, and regulatory audits.
• Lead audit preparation, execution, and follow-up, ensuring timely closure of findings and proactive risk mitigation.
• Maintain comprehensive documentation and data integrity to support audit transparency and compliance.

8. Drive Quality Culture:

• Champion a strong quality culture, fostering accountability, transparency, and continuous improvement.
• Lead by example, setting high standards for ethical conduct, regulatory compliance, and operational excellence.
• Communicate the importance of quality throughout the organization, engaging all employees in quality initiatives.

Key Competencies 

• Strategic Thinking: Ability to set a long-term strategic vision while executing immediate priorities.
• Change Management: Proficiency in leading organizational change and foster a culture centred on quality and compliance, and ensuring employee engagement.
• Decision-making under pressure: make high impact decisions in complex and ambiguous situations.
• Business Acumen: Understanding of the pharmaceutical industry landscape, regulatory requirements, that drive sustainable growth and competitive advantage.
• People leadership: Developing leadership pipelines and fostering a strong organizational culture.
• Organizational savviness: Expert at navigating complex corporate structures, building strong cross-functional relationships and influencing key stakeholders to align quality strategies with business objectives.
• End-to-End Global Network Transformation & Optimization: Proven expertise in designing and leading the transformation of fully integrated global networks, encompassing manufacturing, quality, supply chain, digital, and B2B operations. Adept at driving network optimization through data-driven decision-making, advanced digital technologies, and strategic partnerships. Skilled in fostering a transformation mindset, enhancing agility, and aligning regional and global operations to improve efficiency, resilience, and business performance.

Qualifications & Experience 

• University degree in Pharmacy, Chemistry, or related life sciences (Pharmacist, Chemist, Chemical Engineer).
• Minimum 15 years’ experience in pharmaceutical quality assurance and/or quality control.
• Recognized QP status and valid authorization from relevant health authorities.
• Proven leadership experience in a GMP-regulated environment.
• Aseptic/sterile manufacturing experience highly desired.
• Excellent command of English; proficiency in local language(s) preferred.
• Strong computer literacy and familiarity with digital QMS and LIMS platforms.
• Strong understanding of regulatory requirements and quality standards.
• Excellent strategic planning and organizational skills.
• Ability to drive change and foster a culture of quality and compliance.
• Experience with quality by design and operational excellence initiatives.

In connection with your application, Arcera will collect, process and store personal data about you. Our Privacy Notice for Prospective Employees, also available in German, provides an overview of the personal data that Arcera processes during the application process.

Note: This Privacy Notice may be updated by Arcera, we therefore invite you to consult the latest versions via the above links. In the event of any conflict between the English and German versions of this Privacy Notice, the English version shall prevail.