Head of Quality - CGT Singapore

Singapore, Tuas Singapore

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 Singapore? 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 Cell & Gene Therapy (CGT) Quality Head for the Singapore site, is the leading source of Quality & GMP related expertise and is responsible for providing the strategic leadership and management for the CGT Site`s Quality organization.

Key responsibilities:

  • Leads quality organization (QA, QC) at the Site for CGT, responsible for the final lot disposition of Drug Product /Drug Substance (DP/DS) in CGT.
  • Assures that the site remains under control with respect to GMP for CGT, collaborating with Operations to solve quality issues.
  • Accomplishes corporate business objectives by developing site quality systems and enforcing Regulatory compliance.
  • Acts as Key Account Quality Manager for selected customers.
  • Leads & supports Audits & Regulatory Inspections at the Site for CGT.
  • Leads and directs staff in both QA and QC and ensures their development.
  • Develops compliance related manufacturing and process controls and improves quality systems.
  • Holds responsibility for Quality budget and driving Operational Excellence.
  • Member of the Asset Leadership team.
  • The CGT Quality Head for the asset, is the leading source of Quality and GMP related expertise within the site and is responsible for providing the strategic leadership and management for the CGT Site`s Quality organization.
  • Provide leadership to the CGT Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a team.
  • Develop and execute the Quality strategy commensurate with the overall plan for the company.
  • Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
  • Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
  • Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
  • Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction.
  • Oversee all partners and regulatory authority audits and inspections and corrective action programs in response thereto.
  • Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Lonza’s long-term objectives.
  • Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
  • Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the Lonza on quality and cGMP compliance issues that are specific to the site for CGT.
  • Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations, R&T, and other functions as requested.

Key requirements:

  • Bachelor’s Degree in a Life Sciences, Engineering or Quality Management or related science discipline required.
  • Highly experienced knowledge in GMP manufacturing and Quality Management of products regulated by FDA CBER or CDER or EMA.
  • Proven experience in senior leadership positions in aseptic processing.
  • Expert knowledge of GMP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products; European regulatory requirements as applied to biologicals and sterile product manufacturing.
  • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
  • Regulatory knowledge of CBER, CDER and CDRH, EMA.
  • Strong knowledge of current industry trends and has the ability to use the latest technologies.
  • Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.
  • Excellent organizational and computer software skills.

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.

Vaccination status: As the above role requires you to work on-site*, only fully vaccinated** employees will be shortlisted for the role.  For fully vaccinated applicants, please indicate your vaccination status as “fully vaccinated” when applying for the role.

*In line with the latest advisory from the Ministry of Manpower, from 1 January 2022 only employees who are fully vaccinated or have recovered from COVID-19 within the past 180 days, can return to the workplace.

** Lonza adopts the definition of “fully vaccinated” by the Ministry of Health in Singapore which means that you:

(a) have received the full regimen of WHO EUL vaccines from a specific manufacturer; and

(b) have met the prescribed post-vaccination period for the respective vaccine to be fully effective.

We provide company transport, both ways, at multiple pick up points.

Reference: R44489