Sr. Manager, Quality Control

Role Summary

The Senior Manager, Quality Control will be responsible for day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities including method transfer, qualification, and validation, critical materials management, assay life cycle management, and data review. This role will interact with internal, multidisciplinary teams to ensure successful delivery of results. This role is based in Lexington, MA with a hybrid schedule of 4 days in the office and 1 day remote.

Responsibilities

• Support Quality Control programs for commercial and late-stage clinical drug products, including combination products
• Author, review and approve documents for phase-appropriate qualification/validation and transfer of methods
• Collaborate on the qualification of internal reference standards; maintain the reference standard program across laboratories
• Monitor and trend method and product data
• Enable the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, lab investigations, OOS, deviations, and CAPAs)
• Maintain analytical method life cycle for area of responsibility including method and specification revisions
• Review and approve laboratory data and results, assuring their traceability and integrity
• Generate Certificates of Analysis for product release, and other certificates of GMP testing
• Assure timely and accurate testing at internal and external laboratories in compliance with CGMP, established procedures and regulatory applications
• Manage coordination of samples at external testing laboratories for testing
• Assure availability of critical reagents and other essential materials
• Support preparation of regulatory application content

Qualifications

• BS in a scientific area with 8+ years experience in Quality Control
• Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
• Demonstrated experience in analytical methodologies common for biologics analysis including SEC-HPLC, cIEF, CE-SDS, ELISA, in addition to compendial testing
• Proven ability to manage projects and work with cross-functional teams including CMOs
• Experience in preparing and defending regulatory filings
• Ability to work a flexible schedule to accommodate program priorities, international activities, and travel as needed
• Self-motivated, assertive, and able to act with urgency and passion
• Flexible and adaptable to changing priorities
• Excellent oral and written communication skills for interfacing with all levels of management and departments
• Strong technical/analytical skills to identify and solve problems
• High integrity, accuracy, and attention to detail; ability to make thoughtful, timely decisions
• Resourceful, collaborative, creative, enthusiastic, and results-oriented

Education

• BS in a scientific field

Additional Requirements

• Travel as needed