Senior Specialist, QA (Technical Compliance and Validation)

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Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

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

Key Responsibilities:

• Oversee daily Quality Assurance (QA) operations in line with approved SOPs and policies within a multi-product, cGxP contract manufacturing environment.
• Demonstrate strong motivation and exceptional expertise across all relevant job functions.
• Competently review and approve SOPs, protocols, reports, and records.
• Participate as an active member of cross-functional site teams handling various projects and issues.
• Coordinate multiple activities across departments, ensuring seamless communication and workflow.
• Exhibit excellent troubleshooting abilities, identifying process pathways and developing strategic improvements.
• Possess advanced knowledge of cGMP topics.
• Contribute to regulatory inspections or customer audits as needed.
• Lead or support improvement initiatives and strategic process developments.
• Quickly adapt to leadership roles in various process areas as required.
• Assume supervisory responsibilities in the absence of the direct supervisor.
• Comprehend and communicate the company’s business strategy while maintaining a wide-ranging perspective on operational trends and changes.
• Provide QA oversight to QC/DS lab services, Engineering, and Validation activities, reviewing documents and Trackwise records outside routine operations. Documents may include, but are not limited to, PQR, BLA content, new product introductions, qualification/validation strategies, gap assessments, and customer suspension/decommissioning processes.
• Actively participate in or lead complex investigations into deviations, change controls, CAPA proposals, and discrepancy reports using Root Cause Analysis tools to ensure timely and effective resolution.
• Oversee the proper implementation and timely closure of CAPA related to deviations.
• Support regulatory inspections or customer audits, confidently representing the company as a subject matter expert in QA oversight.
• Offer QA oversight for site-wide improvement projects, collaborating across departments to ensure clear communication and updates.
• Lead or assist in resolving complex process and project issues.
• Mentor and coach junior team members, fostering their development.
• Formulate and present solutions to internal and external teams and management.
• Represent QA Validation/Technical Compliance in decision-making processes during internal and external cross-functional meetings.
• Complete any additional tasks as assigned by the supervisor.

Key Requirements:

• Bachelor's degree or higher in Life Sciences or Pharmaceuticals, with significant experience in Validation and Quality roles within the Biopharmaceutical industry.
• A team player with 5+ years of relevant experience in a similar industry or role.
• Thorough understanding of regulatory requirements and local codes and standards (e.g., FDA, EMEA, ICHQ7).
• Practical and theoretical experience in quality management systems within GM facilities.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.