Senior QA Manager

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Senior QA Manager

Are you passionate about ensuring the highest standards of quality in pharmaceutical products? Do you thrive in a dynamic environment where innovation and excellence are valued? If so, we have the perfect opportunity for you!

As a Senior QA Manager, you will play a crucial role in ensuring the quality and compliance of pharmaceutical products throughout their development and commercialization journey. You'll have the chance to collaborate with talented teams, contribute to cutting-edge projects, and make a meaningful impact on patients' lives.

This role is a 12 month initial fixed term contract.

Responsibilities and Tasks:

• Expert Guidance: Provide GMP/GDP quality assurance expertise during the development and commercialization phases.

• Quality Standards: Ensure all quality activities are initiated and completed according to development stage requirements, maintaining adherence to adequate quality standards.

• Issue Resolution: Lead the resolution of complaints, testing issues, deviations, discrepancies, and Out of Specifications (OOS), proposing Corrective and Preventive Actions (CAPA) as necessary.

• Risk Management: Establish a quality risk management approach based on six sigma concepts, ensuring quality is understood and managed throughout the product life cycle.

• Release Management: Manage activities to support the release of active ingredients, commercial products, and investigational medicinal products, including documentation review and change control assessment.

• Communication and Collaboration: Notify teams of potential quality, regulatory, and lead time issues, represent quality activities in meetings, and assist in GMP/GDP audits at 3rd party sites.

• Documentation: Prepare GMP/GDP agreements, write, review, and approve internal SOPs and other GMP/GDP related documentation.

• System Optimization: Support the review and optimization of the company's pharmaceutical quality system by proposing new procedures or modifications.

Required Qualifications and Experience:

• Educational Background: University degree in Pharmacy, Chemistry, or related technical/science field.

• QA Experience: 5 years+ years of experience in quality assurance of drug substance and/or drug product.

• Industry Knowledge: Understanding of drug substance and/or drug product development, manufacturing processes, quality control, packaging, and distribution.

• Regulatory Compliance: Good knowledge of (c)GMP/GDP’s and ability to interpret and implement quality standards.

• Project Management: Ability to manage complex projects, prioritize workload, and proactively initiate quality activities.

• Language: Applicants must be fluent in English.

• Flexibility: Ability to work fully onsite in Allschwill.

Why Join Us:

• Impact: Contribute to the development and commercialization of innovative pharmaceutical products that positively impact patients' lives.

• Collaboration: Work with talented and passionate teams in a dynamic and supportive environment.

• Growth Opportunities: Expand your skills and advance your career in a global pharmaceutical company committed to excellence.

If you're ready to take the next step in your career and make a difference in the world of pharmaceuticals, apply now!