- Implement and promote the safety message as the top priority for all employees in the organization, and reinforce it across the facility.
- Ensure compliance with Health Authority regulations.
- Collaborate with Sr. Quality Control Manager, Quality Director, and site leadership to improve the Quality Culture.
- Prepare and manage the Quality Control laboratory budget, implementing cost control measures.
- Ensure comprehensive training of personnel in skills, cGMP, and Safety.
- Lead internal audits, regulatory inspections, and customer audits.
- Ensure timely testing, sampling, and release of microbial tests.
- Conduct routine monitoring of classified environments, purified water, process air, and clean utilities.
- Coordinate daily microbiological laboratory activities to align with cGMP and company standards.
- Lead QC groups and support biologics manufacturing, including product testing and system validations.
- Ensure complete and compliant testing to meet production schedules.
- Manage lab documentation, critical reagents, and microbiological cultures.
- Establish and maintain a microbiological laboratory management system.
- Identify and address gaps in compliance with updated regulations.
- Support facility microbial control strategies and coordinate lab investigations and reports.
- Lead laboratory investigations, deviations, and timely closures.
- Support sterility assurance and aseptic process control.
- Report metrics, track schedules, and ensure adherence to timelines.
- Ensure data integrity principles are applied throughout QC processes.
- Hire, develop, and manage professionals within the Quality Control Microbiology group, providing feedback, mentoring, and opportunities for growth.
Minimum Requirements/Qualifications
Education:
- University degree in chemistry, biochemistry, or life sciences, or equivalent experience
Experience:
- 10 years in the pharmaceutical or medical devices industry, Quality Control
- 6 years in a regulated pharmaceutical QC Microbiology laboratory, 4 years of supervisory or management experience
Skills:
- Knowledge of cGMP environment and regulatory expectations
- Technical expertise in QC microbiology and analytical instrumentation
- Strong interpersonal and communication skills in English
- Understanding of applicable regulatory requirements
- Ability to work cross-functionally to meet timelines and objectives
- Experience in Health Agency/internal audits
