Expert, QA (Compliance - Audit Management)

The QA Expert will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in Quality Compliance.

What you’ll get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Daily company bus from the MRT location near your home to and from the Tuas site.

• Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.

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

What you’ll do

• Support day-to-day Quality Assurance activities in accordance with SOPs / Policies for a multi-product and GxP contract manufacturing facility in QA Compliance.

• Strong understanding of advanced cGMP and compliance. Recognized by colleagues as a source of expertise in cGMP and develop others in understanding advance cGMP.

• Deep understanding and knowledge of processes for area oversight.

• Support/Act as Subject Matter Expert for related topics in internal, customer or regulatory audits.

• Identify problem, potential risks and concerns. Work with stakeholders to discuss issues and propose solutions that are compliant, innovative, thorough, practical and consistent with organizational objectives

• Review more complex decisions with supervisor and other departments and propose solutions.

• Strong planning and prioritization of activities without supervision.

• Communicate quality issues and compliance perspective effectively to management and / or global counterparts.

• Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trends in the appropriate area in which the individual operates.

• Own and lead special projects, often complex in nature. Responsible for defining project goals, milestones and timely project completion.

• Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.

• Make suggestions for cost savings and improvements.

• Develop skills as an internal GxP auditor, as required.

• Provide guidance and trains others. May provide oversight to junior team members and/or contractors.

• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate, identify and improve data integrity process.

• Any other tasks as and when assigned by supervisor.

What We’re Looking for

• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, ISPE and ICHQ7)

• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility

• Good leadership skills

• Good interpersonal skills

• Effective Communicator (oral and written)

• Exhibit good quality decision making traits

• Meticulous and Systematic

• Analytical Mind

• Team player, with strong focus on safety, quality and timeline Analytical Mind

• Degree or higher from recognized institution with 10+ years of experience in Validation / Quality unit in the pharmaceutical/biotech industry

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.