The Quality Control Operations Manager will be responsible for implementation and oversight of core Quality Control programs at Beam’s QC Laboratory in Cambridge. The manager will play a key role in the implementation of the AD/QC Center of Excellence (CoE) Laboratory. One of the crucial components to this role will be GMP Release and Stability Testing for our pipeline products. The person will be assisting analysts in the lab and provide technical and GMP guidance and provide training, as needed. This role will also assist the Associate Director in critical reagent, reference standard and sample managements.This role will also check and verify datasheets and ensure data integrity from quality perspectives to deliver quality results and continuously improve QC processes and methods for Beam.
The incumbent will be responsible for day-to-day operations. This role requires daily on-site presence and engagement. The position will report into the Associate Director of the Quality Control.
- Establish and maintain the QC Sample Control program, which includes management of QC samples, reference samples, retain samples, and stability samples.
- Responsible for implementation of systems to ensure compliant receipt, storage, tracking, transfer, and retrieval of samples.
- Serve as LIMS QC Representative; partner with IT Business Partner to ensure LIMS validation and implementation activities are delivered as per the timeline.
- Establish QC Incoming Materials Program and Laboratory Testing.
- Partner with CQV representative to ensure equipment qualification and release milestones are met.
- Participate in GMP validation activities including the development and execution of IQ/OQ/PQ testing.
- Assist with or drive laboratory equipment selection and procurement.
- Interface with Global QC program managers, Quality, Regulatory, Manufacturing, Supply Chain, and Analytical Development.
- Bachelors in a scientific discipline.
- 6+ years’ experience in the pharmaceutical/biotech industry especially in quality control group.
- Knowledge of QC business processes inclusive of sample workflow and testing, certificate of analysis generation, reporting and process trending.
- Experienced with GMP lab management and data review process.
- Experience with LIMS or equivalent qualified software system.
- Experience with Computerized Maintenance Management System.
- Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.