Lead Specialist, Compliance (Audit Management), QA

Randstad – Lonza; Singapore; On-site; SGD 100,000 - 140,000; Full time

Job summary

Lonza Singapore, a global leader in biopharmaceuticals, seeks a Lead Specialist, Compliance (Audit Management) to support GMP activities at our Tuas site. This fully site-based role requires close collaboration with manufacturing and QA teams to uphold high quality and regulatory standards.

You will develop internal GxP auditing skills, lead inspections, manage deviations, and drive cross-functional improvements within Lonza's global QA framework.

Qualifications

• Bachelor's degree in Quality Assurance within the biopharmaceutical sector is required.
• Proven experience in QA operations in a GMP-regulated biopharma environment.
• Strong understanding of quality management systems and GMP compliance requirements.

Responsibilities

• Develop skills as an internal GxP auditor, as required.
• Provide support in regulatory inspections and customer audits as required.
• Lead audit walk-down preparation and provide feedback as required.
• Lead in audit / inspection response as required.
• Lead in complex deviation investigations as required.
• Own 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.

Skills

QA operations

GMP compliance

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Quality Assurance (biopharma)

Tools

Audit management systems

CAPA tracking

Job description

Lead Specialist, Compliance (Audit Management), QA

The Lead Specialist, Compliance (Audit Management) will support Audit activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility. 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.

Key responsibilities

• 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
• Own 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

About you

• 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
• 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

About us

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. 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.