Lead Specialist, Compliance (Audit Management), QA

About the role

Lonza is hiring a Lead Specialist, Compliance (Audit Management) for a fully site-based role at its multi-product, cGxP contract manufacturing facility in Tuas, Singapore. The specialist supports audit activities in line with approved SOPs and policies, working closely with colleagues in person.

Key responsibilities

• Develop skills as an internal GxP auditor as required.
• Support backroom and front room activities during regulatory inspections and customer audits as required.
• Lead audit walk-down preparation and give feedback as required.
• Lead audit and inspection responses as required.
• Lead complex deviation investigations as required.
• Own the documents of the assigned Quality Process when applicable.
• Develop skills to become a Qualified Trainer in your area of expertise.
• Act as Subject Matter Expert in one or more areas of expertise.

Required profile

• 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 organisational abilities.
• Detail-oriented, structured, a strong team player focused on safety, quality and meeting timelines.

What we offer

• Competitive compensation programs that recognise high performance.
• Comprehensive medical insurance, with family members at partially subsidised premiums.
• Company transport from designated MRT stations to and from the Tuas site.
• Full employee benefits suite.
• Cross-functional projects and global exposure for professional growth.