Band
Level 5
Job Description Summary
As Quality Operations Manager, you will play a key leadership role in safeguarding product quality, patient safety, and reliable supply from our site. You will provide strategic and operational oversight of Quality Operations, ensuring that batches are released in accordance with registered specifications, GMP requirements, and Marketing Authorization commitments.
In this role, you will lead and develop a team of QA Specialists and Release Responsible Persons or Qualified Persons, while acting as the site’s Lead Qualified Person. You will partner closely with Production, QC, AS&T, Engineering, MS&T, and other site functions to strengthen quality culture, drive continuous improvement, and ensure inspection readiness.
Job Description
Major Accountabilities:
- Provide end-to-end oversight of Quality Operations across the site, including inbound and outbound QA, Master Batch Record review and approval, product release, and QA Operational Excellence.
- Lead and develop the QA Operations team, including QA Specialists and Release Responsible Persons or Qualified Persons, ensuring appropriate resources, capabilities, and succession planning.
- Oversee QA support for QC, AS&T, Production, Engineering, and MS&T activities, including shop floor collaboration, maintenance, calibration, validation, and lifecycle management.
- Lead batch release activities and perform QP certification of batches in compliance with registered specifications and GMP requirements.
- Ensure Quality Operations procedures are reviewed, updated, and approved in line with site and regulatory requirements.
- Provide input into the site master plan, site quality plan, GMP training needs, and continuous improvement initiatives.
- Review and approve site-level OOS, OOT, deviations, complaints, and related CAPAs, ensuring timely and effective implementation.
- Support Health Authority inspections and internal audits, and ensure local implementation of Marketing Authorization variations.
Obligatory requirements:
- Master’s degree in a scientific discipline.
- 5+ years of experience in a similar role within the pharmaceutical or biotech industry.
- Proven people management and leadership skills, with the ability to develop and motivate teams.
- Current Qualified Person certification or the required technical background to obtain QP certification.
- Strong knowledge of GMP, batch release processes, quality systems, and regulatory requirements.
- Demonstrated agile mindset, including setting clear priorities, collaborating openly, and using feedback to drive continuous improvement.
- Fluent in English; fluency in Dutch is desirable.
- Experience in a sterile pharmaceutical manufacturing environment is desirable.
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.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Skills Desired
