QA Operations Team Leader - Release Support (m/w/d), Kundl, Tirol

Novartis Farmacéutica; Kundl; Vor Ort; EUR 65 000 - 90 000; Vollzeit

Zusammenfassung

A leading company in pharmaceutical manufacturing seeks a QA Operations Team Leader in Kundl. This role involves overseeing the Release Support Team, ensuring compliance with cGMP standards and regulations while contributing to vital medicines for patients.

Leistungen

Attractive incentive program

Modern company pension scheme

Childcare facilities

Learning and development opportunities

Qualifikationen

• Minimum 3 years of experience within QA, 2 years management experience.
• Thorough knowledge of cGMP requirements.
• Fluent in English and German.

Aufgaben

• Lead the QA Operations Release Support Team.
• Ensure compliance with cGMP and regulatory requirements.
• Handle quality escalations and collaborate in audits.

Kenntnisse

Communication

Problem Solving

Analytical

Leadership

Ausbildung

University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, or Microbiology

Jobbeschreibung

QA Operations Team Leader - Release Support (m/w/d), Kundl, Tirol

Job ID REQ-10045133

May 16, 2025

Austria

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!

About the Role

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
• 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.

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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area Quality

Job Type Full time

Employment Type Regular

Shift Work No

Adjustments for Applicants with Disabilities

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.