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Director of Quality Assurance

1 month ago

Waltham, Massachusetts, United States RPM ReSearch Full time
Job Summary

The Director of Quality Assurance is responsible for overseeing all aspects of the Quality Assurance function, including the development, implementation, and maintenance of an effective Quality Management System. This includes ensuring compliance with relevant regulations and standards, such as FDA and EMA guidelines.

The ideal candidate will have a strong background in quality leadership, with experience in managing quality systems, supplier quality, and quality operations. They will be able to coach and support personnel in a cGMP manufacturing environment, and have a solid understanding of GMP regulations and international guidelines.

The Director of Quality Assurance will be responsible for managing and supporting a variety of processes, including document control and change control. They will also be responsible for material and finished goods disposition and release, and will need to be able to lead and work with cross-functional teams.

Key Responsibilities
  • Develop, implement, and maintain an effective Quality Management System
  • Ensure compliance with relevant regulations and standards
  • Manage and support quality systems, supplier quality, and quality operations
  • Coach and support personnel in a cGMP manufacturing environment
  • Manage and support document control and change control processes
  • Responsible for material and finished goods disposition and release
  • Lead and work with cross-functional teams
Requirements
  • BS preferred, in a scientific/technical discipline with 8+ years of experience in a quality leadership position
  • MS in a scientific/technical discipline is a plus
  • Significant experience in supporting functional areas, such as PD, Manufacturing, QA, Engineering, and EHS
  • Experience with writing deviations, lab investigations, and OOS required
  • Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities
  • Solid knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals
  • Ability to apply GMP regulations and international guidelines to all aspects of the position
  • Ability to write reports, business correspondence, and procedure manuals
  • Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
  • Ability to effectively present information to employees, top management, public groups, and/or boards of directors
  • Must be able to assess and utilize software and customized programs to meet QC business needs