QC Microbiological Laboratory Supervisor

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, including protecting the environment, ensuring our food is safe, and helping to find cures for cancer. DESCRIPTION How will you make an impact? As QC Microbiological Laboratory Supervisor, you will lead and coordinate Microbiological Quality Control laboratory activities by effectively planning, organizing, and monitoring analytical operations to ensure on-time delivery, Right First Time (RFT) performance, regulatory compliance, and customer satisfaction. What will you do? Ensure the effective management of the Microbiological Quality Control laboratory by leading, coordinating, and developing the assigned team to perform all required microbiological testing in compliance with safety regulations, approved methods, applicable regulatory requirements (EU GMP, US GMP, FDA regulations, and other relevant national regulations), marketing authorization dossier requirements, and company quality standards. Provide technical leadership and oversight for laboratory operations supporting pharmaceutical manufacturing, from raw material and incoming material testing through finished product release and stability studies. Support the Quality Department in the preparation for and execution of client and regulatory authority audits and inspections (e.g., FDA, EMA, AIFA,) by coordinating cross-functional activities, managing audit readiness, and ensuring the timely availability of required documentation and responses. Draft and review analytical specifications, study protocols, reports, analytical methods, and Standard Operating Procedures (SOPs) in compliance with applicable national and international GMP regulations and company quality standards. Participate in customer meetings and conference calls to discuss technical topics within your area of expertise. Lead laboratory investigations, including Out-of-Specification (OOS) results, deviations, Out-of-Trend (OOT) results, and the definition and implementation of appropriate corrective and preventive actions (CAPAs). Oversee Method Development, Method Validation, and Method Transfer activities for assigned projects, as applicable. Collaborate with the Manager to define and monitor the department budget and CAPEX, ensuring the efficient management of the Microbiological QC laboratory. Drive operational excellence by mentoring team members, optimizing laboratory workflows, implementing continuous improvement initiatives, and promoting Lean and Practical Process Improvement (PPI) principles while maintaining the highest quality standards. Lead, coach, and develop the assigned team by setting objectives, monitoring performance, recognizing achievements, and identifying training and development needs to build a high-performing, engaged, and accountable organization. REQUIREMENTS Bachelor's degree or higher in Biology, Microbiology, Biochemistry, Pharmaceutical Chemistry and Technology (CTF), or a related scientific discipline. Multiple years of experience in Microbiological Quality Control within the pharmaceutical and/or biotechnology industry. At least 3 years of experience in a people leadership role managing laboratory operations, including scheduling, resource planning, and process improvement initiatives. Experience in pharmaceutical manufacturing, preferably in an aseptic environment. Strong knowledge of cGMP, FDA regulations, EU GMP, ICH guidelines, and pharmaceutical quality systems. Strong knowledge of Quality Risk Management principles, risk assessment methodologies, and Root Cause Analysis tools. Strong understanding of ALCOA+ Data Integrity principles and regulatory expectations. Excellent technical writing skills, including experience drafting SOPs, investigations, analytical methods, protocols, reports, and regulatory documentation. Demonstrated leadership, problem-solving, and team management skills. Excellent interpersonal and communication skills, with the ability to effectively interact with stakeholders at all organizational levels. Proficiency in managing conflicting priorities, while working under time constraints, and in a dynamic team environment. Proficiency with Microsoft Office applications, Laboratory Information Management Systems (LIMS), and electronic Quality Management Systems (eQMS). Professional certifications in Quality Systems, Regulatory Compliance, Lean Six Sigma, or Project Management are considered an advantage.