Department: Quality Assurance
Job Title: QA cGMP Compliance Supervisor
Description:
ImmunoGen, Inc. is in search of a motivated team player to join the Quality Assurance department. The QA cGMP Compliance Supervisor will be responsible for providing cGMP compliance support to the Norwood facility by directing and prioritizing the day-to-day activities of the QA cGMP Compliance group. The QA cGMP Supervisor will also be responsible for training, supervising, and mentoring QA cGMP Compliance Specialists.
Job duties and responsibilities:
Reviews and approves Document Change Controls for SOPs, test methods, raw material specifications, method transfers, product intermediate, drug substance and final drug product specifications, protocols (validation, stability, etc.), and master batch records, both internal & external
Approves SOPs, test methods, raw material and product intermediate specifications, protocols (validation, stability, etc.) and master batch records, both internal & external
Reviews and approves Change Controls for equipment/facilities/utilities/methods
Reviews and approves batch records and quality control testing and performs release of product intermediates and drug substances
Performs manufacturing area and labeling clearances as well as inspection of labeled clinical material
Reviews and approves CAPAs
Authors or revises SOPs
Reviews and approves preplanned, minor, and major deviations; reviews critical deviations
Assists in performing investigations and reviewing investigation reports
Leads internal auditing and participates in external auditing
Responds or manages responses to partners regarding manufacturing and/or documentation issues
Develops and delivers cGMP training
Monitors departmental metrics: Batch record review turnaround time, Deviations, Change Controls, Investigations, and CAPAs
May participate in development of departmental budget
Trains, supervises, and mentors junior staff
Performs goal setting and performance evaluations for junior staff
Directs and prioritizes day-to-day activities of QA cGMP Compliance group
Interacts with various personnel from all departments in activities listed above
Job Requirements:
The qualified candidate will possess a BS or MS in life sciences with at least 6 to 8 years of overall experience in the pharmaceutical/biotechnology industry. At least 5 of the 6 to 8 years must have been in Quality Assurance.
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