QMS Senior Specialist

The actual location of this job is either in Basel, Colmar or Bornem . Relocation assistance is available for eligible candidates and their families, if needed.

The Senior Quality Systems Specialist is responsible for driving the development, harmonization, and continuous improvement of the global Quality Management System (QMS) across a multi‑site healthcare company. Serving as a global subject matter expert in GMP, GxP, ISO, and compliance expectations across food (supplements), pharmaceutical, and healthcare product categories, this role provides cross-functional leadership and advanced quality systems expertise to ensure operational excellence, audit readiness, and regulatory compliance across all global operations. 

As part of the corporate enabling function team, this senior position partners closely with regional and site quality leaders, global suppliers, and other stakeholders to enhance quality system maturity, standardize processes, and support business, quality, and compliance initiatives. 

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• A variety of benefits dependent on role and location.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

• Lead global governance, harmonization, and continuous improvement of QMS processes aligned with GMP, GxP, ISO, and industry best practices, and food, feed, and pharmaceutical regulations. 

• Co-develop and lead a global inspection‑readiness program and initiatives, and conduct corporate audits, provide pre, during, and post inspection support across manufacturing sites, labs, warehouses, and corporate functions to ensure continual regulatory and customer compliance. 

• Oversee raw material and supplier portfolio, maintain technical and quality relationship, conduct supplier audits and compliance assessments focused on GMP/GxP adherence, documentation integrity, and regulatory readiness across food and pharma suppliers. 

• Participate in process and data management of global QMS digital platforms and tools, as fit for purpose GMP standards, and additionally drive standardization, automation, and improved user experience across sites and regions. As such, serve as a global SME for core QMS processes (document control, change, CAPA, and risk management) and develop and manage key performance metrics related to QMS effectiveness. 

• Lead global certification and recertification activities (ISO, GMP, HACCP), coordinating documentation, readiness reviews, and interactions with certification bodies. 

• Support global quality initiatives—including QMS integrations, system transitions, and cross‑division improvement projects—to strengthen harmonization and overall QMS maturity. 

• Facilitate global collaboration by acting as a liaison between sites, quality teams, and corporate functions to advance QMS maturity and compliance. 

• Bachelor’s degree in a scientific discipline (e.g., Quality, Life Sciences, Engineering) or equivalent experience; advanced degree preferred. 

What we are looking for:

• 7-10+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance within pharmaceutical, food, or healthcare industries. 

• Strong knowledge of QMS standards and regulatory frameworks (GMP, GxP, ISO, HACCP) and audit practices. 

• Proven experience leading multi-site or global quality initiatives and corporate-level auditing. 

• Strong organizational skills with the ability to manage multiple priorities and meet deadlines. 

• Strong analytical and digital skills, with proficiency in Microsoft Office, Power BI, SharePoint, SAP, and QMS platforms. 

• Excellent communication skills (oral and written), with the ability to engage senior leadership, auditors, regulators, and global stakeholders.  

• Strong problem-solving capability and a continuous improvement mindset; Lean/Six Sigma certification is a plus. 

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.