​QA Expert (Development)

​QA Expert (Development)

Are you ready to be at the forefront of ensuring the quality and compliance of pharmaceutical products on a global scale? Do you thrive in a fast-paced environment where your expertise can drive impactful change? If so, we have an exciting opportunity for you!

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Responsibilities and Tasks:

• Release Management: Manage activities to support the release of drug substances, products, and intermediates for development or pre-commercialized products worldwide.

• Partnership Liaison: Drive all QA-related topics and serve as the main QA liaison for partner collaborations in development activities.

• Compliance Oversight: Ensure compliance with quality assurance standards throughout the design, development, manufacture, and supply of pharmaceutical products.

• Team Supervision: Supervise the GMP/GDP Development QA group within the Quality Assurance department.

• Issue Resolution: Lead issue resolution and QA review for CMC teams and supply chain stakeholders.

• Quality Improvement: Lead initiatives to improve quality internally or through partner collaborations.

• Complaint Investigations: Manage investigations of complaints at CMO level and ensure timely completion.

• Quality Agreements: Lead the implementation of relevant quality agreements and manage communication with QA peers from partner companies.

• Regulatory Compliance: Notify management of potential quality and regulatory issues and support regulatory agency inspections.

• Quality System Optimization: Monitor the efficiency of the pharmaceutical quality system, establish relevant KPIs, and implement improvements when necessary.

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Required Qualifications and Experience:

• Education: Advanced degree in Pharmacy, Chemistry, or related technical/science field.

• Experience: At least 10 years in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control.

• Regulatory Expertise: Proven experience related to Health Authorities inspection, risk assessment, and CAPA management.

• Industry Knowledge: Thorough knowledge of manufacturing and control of drug substances, products, and combination products.

• Leadership Skills: Several years of experience leading cross-functional teams, with strong interpersonal and influencing skills.

• Regulatory Compliance: Thorough knowledge of (c)GMP/GDP and international regulatory requirements.

• Communication: Clear and professional communication skills in English; proficiency in French, German, or Italian is advantageous.

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Why Join Us:

• Impactful Work: Contribute to ensuring the quality and compliance of pharmaceutical products on a global scale.

• Collaborative Environment: Work in a dynamic and supportive team environment where your expertise is valued.

• Development Opportunities: Grow your skills and advance your career in a renowned pharmaceutical company committed to excellence.

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If you're passionate about ensuring the highest standards of quality in pharmaceutical manufacturing and ready to make a significant impact, apply now!