Head of QA Compliance (m/f/d)

On behalf of our client, a global leading pharmaceutical company focused on safeguarding individuals from cardiovascular diseases and pioneering innovative cancer treatments, and backed by billions in investment, which is expanding their production capabilities with a cutting-edge site in Bavaria and is poised to become a hub of groundbreaking advancements, we are currently looking for:

Head of Regional QA Compliance (m/f/d)

Main Responsibilities:

• Lead a team handling pharmaceutical-technical complaints and ensure the highest quality standards.
• Develop and implement training concepts within the Regional GMP/GDP QA department.
• Oversee the creation, review, and approval of Annual Product Quality Reviews (APQRs) as the Marketing Authorization Holder.
• Coordinate and implement necessary changes to manufacturing and import permits, and communicate with relevant authorities.
• Support the compilation of relevant GMP/GDP documents for the approval of new medicines and during inspections and audits by authorities.
• Guide and develop direct reports through regular feedback and coaching.
• Promote and establish a team culture that reflects and represents corporate values.

Main Requirements:

• Successfully completed higher education, ideally in Pharmacy, Engineering, or Natural Sciences.
• 6-8 years of relevant professional experience in the pharmaceutical industry and GMP-controlled environment, including 4 years in Quality Assurance or Quality Management.
• Profound understanding and experience in handling complaints in the GMP/GDP environment.
• Practical experience in developing and implementing training concepts in the GMP area.
• Extensive knowledge in creating APQRs and communicating with authorities regarding manufacturing and import permits.
• Familiarity with national and international pharmaceutical law.
• Extensive knowledge in data processing and analysis.
• Excellent skills in moderation, communication, and motivation across various disciplines and cultures.
• High level of independence, responsibility, and decisiveness.
• Strong team spirit, flexibility, and quick comprehension.
• Very good German and English skills, both written and spoken.

What’s in it for you?

• Modern and global organizational structures.
• Attractive salary with performance-based bonuses.
• New production site with an exciting project pipeline.
• Located in the beautiful region of Bavaria.
• A culture of mutual respect and continuous learning, characterized by diversity and inclusion.
• Opportunity for personal development and to contribute to the future of the organization.

Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.

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