Job Description Summary
Are you interested in leading a dynamic Quality Assurance team in the pharmaceutical manufacturing realm and making a real-world impact? Novartis DS Kundl invites you to be our Manager of the Quality Operations Batch Release Support Team. In this role, your expertise will be crucial for ensuring compliance with cGMP, Quality Assurance Agreements, and various regulatory requirements. Not only will you be a key player in supplying essential medicines to patients, but you'll also be instrumental in meeting the objectives of our site and our external customers. Join us in our mission to improve lives, apply today!
Job Description
Major accountabilities:
Leadership of QA Operations Release Support Team according to cGxP standards in the area of responsibility. This includes:
- 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
Minimum Requirements:
- Educational Background: Minimum University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
- Experience: Professional experience in Pharmaceutical industry, with direct experience with Pharmaceuticals, Biopharmaceutical or API products and at least 3 years within QA, min. 2 years of management and/or project management experience, thorough knowledge of cGMP requirements as well as proven track record with FDA / EMA and other Health Authorities.
- Skills: Strong communication, analytical, and pragmatic problem-solving and resilience skills. Proven people leadership and stakeholder management experience.
- Languages: Fluent in English and German.
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €65.605,54/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Attachments
Skills Desired
Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological IntelligenceSimilar Jobs
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What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
