We are currently looking for a Laboratory Operations Manager for a leading player in the Medical Device Manufacturing Industry with a legacy of more than 40 years in the world. This position requires your urgent attention.
- Reporting to: Quality Director
- Based in Penang
- Attractive remuneration and benefits package
the job
- Champions a culture of patient safety and product quality, ensuring all laboratory operations meet FDA, GMP, ISO, and European regulatory standards.
- Leads the maintenance and ongoing enhancement of the analytical laboratory’s Quality System, driving continuous improvement and regulatory compliance.
- Oversees daily laboratory operations, ensuring efficient scheduling, testing, data review, and timely release of results in alignment with performance objectives.
- Reviews and approves all critical laboratory documentation, including test results, protocols, reports, and SOPs, to ensure accuracy and compliance.
- Manages the transfer of validated analytical methods from donor labs, ensuring smooth integration and adherence to established procedures.
- Selects, qualifies, and oversees external contract laboratories, ensuring all outsourced activities meet internal quality and regulatory expectations.
- Provides expert technical support in resolving method challenges, equipment issues, out-of-specification results, and other analytical troubleshooting needs.
- Drives staff development through performance management, training, and mentorship, fostering a high-performing and compliant laboratory team.
- Leads budgeting, resource planning, and talent acquisition for laboratory operations, while actively contributing to site-level strategic initiatives.
- Ensures robust execution of change control, deviations (NCEP), and CAPA processes, with timely closure, root cause identification, and effective corrective actions.
the experience
- Bachelor’s degree in Analytical Chemistry, Chemistry, or Analytical Instrumentation (or equivalent).
- Minimum of 8 years’ experience in pharmaceutical or commercial analytical testing laboratories, including at least 5 years managing chemists or laboratory resources.
- Proficient in analytical method development and validation, with hands-on experience operating instruments such as HPLC, GC-MS, and UV-Vis. Experience working with enterprise laboratory systems (e.g., LIMS, CDS) and within ISO-compliant or regulated environments is highly advantageous.
- Professional certification as a Chemist is preferred.
