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QA Operations Release Support Team Lead
vor 3 Wochen
About the Job
">The Manager of Quality Operations Batch Release Support Team will be responsible for leading a dynamic QA team in the pharmaceutical manufacturing realm, ensuring compliance with cGMP, Quality Assurance Agreements, and regulatory requirements.
">This role requires strong leadership skills, expertise in GxP functions, and a proven track record in regulatory compliance.
">The ideal candidate will have at least 3 years of experience within QA, min. 2 years of management and/or project management experience, and a minimum University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
">- ">
- Main Responsibilities:">
- Leadership of QA Operations Release Support Team according to cGxP standards in the area of responsibility.">
- Oversight of GxP functions across site and ensure product quality.">
- Ensure regulatory compliance and implementation of corporate quality standards and regulations.">
- Ensure planning and tracking of batch record review and release related activities to maintain business continuity.">
- Ensure timely and thorough exception (deviation, OOX and complaint) handling including global quality escalation whenever needed.">
- Ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations.">
- Collaboration in internal and external audits.">
- Ensure any collaborations with 3rd parties are performed with adequate Quality Assurance Agreements in place.">
- Participation in the compilation, revision and approval of validations, transfers, SOPs and other GxP related documents as applicable.">
- ">
- Requirements:">
- Education: Minimum University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.">
- Experience: At least 3 years within QA, min. 2 years of management and/or project management experience.">
- Skills: Strong communication, analytical, and pragmatic problem-solving and resilience skills. Proven people leadership and stakeholder management experience.">
- Languages: Fluent in English and German.">
- ">
- Benefits:">
- A market-competitive base salary.">
- An attractive incentive program.">
- A modern company pension scheme.">
- Childcare facilities.">
- Learning and development opportunities.">
- Worldwide career possibilities within the Novartis group.">
- ">
- Commitment to Diversity and Inclusion:">
- Noartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.">
- Career Opportunities:">
- Not the right Noartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.">
Why Choose Noartis?
">Noartis is a leading pharmaceutical company dedicated to improving lives through innovative science and diverse teams. We strive to create a collaborative work environment where our employees can thrive professionally and personally.
">Join us in our mission to improve lives, apply today
