@ MacroGenics
  • Post Date : Jan 10, 2022
  • Apply Before : Mar 22, 2022
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Job Description

Summary of Position

The Manager, Manufacturing Compliance will lead the Manufacturing Compliance group at MacroGenics. This group is responsible for the completion of deviation investigations, CAPAs and change controls associated with biopharmaceutical drug substance manufacturing operations at MacroGenics’ cGMP production facilities. He/she will assign and prioritize activities to staff, motivate the team and drive actions to ensure adherence to overall production and lot release schedules while maintaining a high level of quality and compliance. The position will work in partnership with Manufacturing Operations, Quality Assurance, BioPharmaceutial Development and other site functions to ensure timely and collaborative completion of work.

Responsibilities and Job Duties

  • Manages a team of Associates responsible for completion of deviation investigations, nonconformances, CAPAs and change controls associated with biopharmaceutical drug substance manufacturing operations for early-stage clinical and late-stage/commercial cGMP manufacturing facilities, including upstream, downstream and support functions.
  • Ensures that all work is performed in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements and assure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
  • Ensures thorough, comprehensive and timely investigations are performed to identify root cause and assess product impact. Ensures corrective/preventive action plans are identified which address underlying cause and action items are assigned to appropriate groups.
  • Ensures all staff are adequately trained on relevant cGMP documentation.
  • Provides continuous development for Associates through activities such as special developmental assignments and associated technical training programs. Leads by example, recognizes and celebrates successes, and addresses performance and behavioral issues.
  • Recruits, motivates, retains and develops employees. Builds and sustains employee engagement by creating an environment where individuals and teams can excel. Establishes team and individual goals and objectives in alignment with site goals and priorities. Identifies performance improvement targets and metrics.
  • Implements and supports business processes and standardization of work to drive continuous improvement. Identifies areas for improvement in manufacturing efficiency, productivity, safety and compliance.
  • Champions the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites.
  • Collaborates with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
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