Job Description
We are seeking a Quality Control (QC) Laboratory Manager to oversee the laboratory operations, ensuring it runs smoothly and meets site needs. As a leader, you will collaborate with the QC leadership team, motivate and support the broader QC team, while promoting safety and 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.