Vice President of Quality and Regulatory Affairs

1 month ago


Brighton, Michigan, United States Bryllan LLC Full time
Job Description

Bryllan LLC, a rapidly growing Contract Manufacturing Organization, is seeking a highly experienced Vice President of Quality and Regulatory Affairs to join its senior management operating team. The ideal candidate will have a strong background in pharmaceutical quality, regulatory affairs, and leadership, with a proven track record of driving quality and compliance initiatives in a sterile manufacturing environment.

The successful candidate will be responsible for developing and implementing quality and regulatory strategies, ensuring compliance with cGMP and other regulatory requirements, and leading the Quality Assurance and Regulatory Affairs teams. They will also be responsible for mentoring and developing staff, providing guidance on regulatory compliance, and serving as a key member of the Senior Leadership team.

Key Responsibilities:

  • Develop and implement quality and regulatory strategies to ensure compliance with cGMP and other regulatory requirements
  • Lead the Quality Assurance and Regulatory Affairs teams, providing guidance and mentorship to staff
  • Provide advice to the Leadership Team on regulatory compliance issues
  • Serve as the principal spokesman with customers, regulatory agencies, and other stakeholders on matters of regulatory compliance
  • Work with all Bryllan employees to align and integrate the quality management system in all operational activities

Requirements:

  • 15+ years of experience in pharmaceutical quality, regulatory affairs, and leadership
  • Extensive experience in cGMP and other regulatory compliance requirements
  • Proven track record of driving quality and compliance initiatives in a sterile manufacturing environment
  • Strong leadership and management skills, with the ability to mentor and develop staff
  • Excellent communication and presentation skills

Preferred Qualifications:

  • M.B.A. or other relevant advanced degree

Physical Requirements:

  • Ability to sit, stand, and/or walk for no less than 8 hours a day
  • Ability to travel domestically and internationally via plane, train, and car as required


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