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The Lead Specialist will support audit activities, manage regulatory inspections, and lead complex deviation investigations within a cGxP manufacturing facility. They are also responsible for developing internal audit skills and acting as a subject matter expert in quality processes.
Candidates must hold a bachelor's degree and possess proven experience in Quality Assurance within a GMP-regulated biopharmaceutical environment. A solid understanding of quality management systems and regulatory guidelines such as FDA, EMA, and ICH is required.
The Lead Specialist, Compliance (Audit Management) will support Audit activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
An agile career and dynamic working culture in a global life sciences leader.
An inclusive and ethical workplace that values diversity and integrity.
Competitive compensation programs that recognize high performance.
Professional growth opportunities through cross-functional projects and global exposure.
Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
Company transport provided from designated MRT locations to and from the Tuas site.
Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits
Develop skills as an internal GxP auditor, as required
Provide support in backroom / front room in regulatory inspections and customer audits as required
Lead in audit walk down preparation and provide feedback as required
Lead in audit / inspection response as required.
Lead in complex deviation investigations as required.
Owns documents of the assigned Quality Process when applicable
Develop skills to be Qualified Trainer in area of expertise
Subject Matter Expert in one or more area of expertise
Bachelor’s degree with relevant experience in Quality Assurance within the biopharmaceutical sector.
Proven experience in QA operations in a GMP-regulated biopharma environment.
Practical experience collaborating with cross-functional manufacturing teams.
Solid understanding of quality management systems and GMP compliance requirements.
Familiarity with regulatory guidelines such as FDA, EMA, and ICH.
Strong analytical, problem-solving, communication, and organizational abilities.
Detail-oriented, structured, and a strong team player with a focus on safety, quality, and meeting timelines
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.
Making the Medicines of Tomorrow
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow. Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs. For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
Offices: Muenchensteinerstr. 38, Basel, 4002, CH · 8830 Biggs Ford Road, Walkersville, MD 21793, US · 35 Tuas South Ave 6, SG, 637377, SG · 228 Bath Road, Slough, Berkshire SL1 4DX, GB · Rottenstrasse 6, Visp, VS 3930 , CH
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