Associate Manager, QA Operations (Lot Review)

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A leading life sciences company based in Singapore seeks an Associate Manager for QA Operations (Lot Review) to supervise quality assurance activities in a GxP facility. Responsibilities include leading operational excellence initiatives, reviewing compliance documents, and supporting regulatory inspections. The ideal candidate holds a degree and possesses strong leadership and analytical skills. A commitment to safety and quality is essential, along with effective communication skills. Competitive benefits and an inclusive culture offered.

Benefits

Daily company bus to site

Fully paid medical insurance

Compensation programs that recognize high performance

Qualifications

• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Meticulous and systematic mindset.
• Team player with strong focus on safety and quality.

Responsibilities

• Supervise day-to-day Quality Assurance activities.
• Review and approve procedures, documents, and investigations.
• Lead Operational Excellence and Continuous Improvement initiatives.

Skills

Leadership and interpersonal skills

Effective communication

Analytical mindset

Decision making traits

Education

Degree or higher from recognized institution

Job description

We are looking to hire a Associate Manager, QA Operations (Lot Review). The Associate Manager will supervise the day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility, which includes ensuring key interfaces with other functions e.g. Manufacturing, Quality Control (QC), Engineering (ENG), Manufacturing Science and Technology (MSAT), are well-fronted to ensure smooth day-to-day running. In addition, the individual is expected to drive consistency between the different teams within the department and to mediate/ resolve both process and operational issues in his/her area of responsibilities. Administratively, the individual is responsible for measuring the team’s performance against the Key Performance Indicators (KPIs) of the Department and to drive continuous improvements efforts.

What you will 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 enrol family members at partially subsidized premiums.

Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do

• Strong understanding of advanced cGMP and compliance; and develop others in understanding advanced cGMP
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, CAPAs, change requests and gap assessment associated with the assigned Quality Process
• Strong planning and prioritization of activities for self and team without supervision.
• Identify problems, troubleshoot and complete or coordinate corrective action with cross functional departments.
• Lead Operational Excellence and Continuous Improvement initiatives.
• Involvement in global harmonization/ efficiency projects; lead aspects of global projects within specific areas
• Provide support / participate in regulatory inspections and customer audits as requiredParticipates in Customer related meetings, when applicable
• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate, identify and improve data integrity process.
• Assist management in the definition, development and provision of career progression paths for individuals.
• Carry out performance reviews and recommend advancements for team members where reasonable.
• Any other tasks as and when assigned by Manager/Director.

What we are looking for:

• Degree or higher from recognized institution
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
• Good leadership and interpersonal skills
• Effective Communicator (oral and written)
• Exhibit good quality decision making traits
• Meticulous, Systematic and Analytical mindset
• Team player, with strong focus on safety, quality and timeline

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.