We are seeking a Quality Control (QC) Laboratory Manager to join our team. In this role, the individual will oversee a team of skilled QC supervisors and professionals to ensure the laboratory runs smoothly, meeting the operational needs of the site. As a leader, the Manager will collaborate closely with the QC leadership team, while also motivating and supporting the broader QC team. The role will focus on promoting safety and maintaining high-quality standards within the laboratory environment.
Key Responsibilities:
- Lead, inspire, and guide the QC team to enhance productivity by providing clear task instructions and setting goals to optimize performance.
- Oversee QC Supervisors and the QC Planner to ensure successful batch release plans and adherence to schedules.
- Establish, track, and report on key performance indicators (KPIs) related to batch release performance.
- Collaborate with the QC Trainer to ensure training programs are thorough, proactive, and meet departmental needs.
- Foster a culture of continuous improvement and process simplification.
- Ensure the laboratory remains audit-ready at all times, taking ownership of your area during regulatory inspections and corporate audits.
- Participate in internal and external audits, addressing and resolving audit findings.
- Set annual objectives, conduct performance reviews, and manage the growth and development of team members.
- Coordinate with cross-functional teams on sampling, testing, and adherence to schedules and priorities.
- Ensure compliance with laboratory documentation and computerized systems, adhering to data integrity policies and regulatory standards.
- Ensure adherence to cGMP, industry regulations, and company policies in all laboratory processes.
- Cultivate a positive, inclusive environment that supports continuous development and growth for all lab personnel.
- Support the resolution of specific quality issues within manufacturing as required.
- Oversee the execution of chemical testing for raw materials, intermediates, and finished products, ensuring timely completion.
- Undertake additional tasks or projects as assigned by senior management.
- Communicate system issues to management to ensure prompt corrective and preventive actions are implemented.
- Manage the day-to-day operations of the lab, ensuring long-term goals are achieved and providing necessary training and support to the team.
Qualifications:
- M.Sc. or B.Sc. in Chemistry or a related field.
- A minimum of 3 years' experience in a laboratory role within the pharmaceutical industry, with supervisory experience.
- In-depth knowledge of QA/QC operations, including test methods, specifications, and laboratory equipment.
- Experience working in a GMP-regulated environment.
- Strong conflict resolution and interpersonal skills, with the ability to work effectively within cross-functional teams.
