Associate Director Audit and Inspection Management Lead

1 day ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Description

Vertex Pharmaceuticals is seeking a highly skilled and experienced Associate Director to lead our Audit and Inspection Management team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Develop and implement a comprehensive audit and inspection management program to ensure compliance with regulatory requirements and industry standards.
  • Lead a team of auditors and inspectors to conduct internal and external audits, and provide guidance and support to ensure the quality and compliance of our products and processes.
  • Collaborate with cross-functional teams to identify and mitigate risks, and implement corrective actions to ensure compliance with regulatory requirements and industry standards.
  • Develop and maintain relationships with regulatory agencies and industry partners to ensure compliance with regulatory requirements and industry standards.
  • Provide training and development opportunities to team members to ensure they have the necessary skills and knowledge to perform their duties effectively.
Requirements:
  • Bachelor's degree in a relevant field, such as quality assurance, regulatory affairs, or a related field.
  • At least 8 years of experience in a quality assurance or regulatory affairs role, with a minimum of 3 years of experience in a leadership or management role.
  • Proven track record of success in leading audit and inspection management programs, and ensuring compliance with regulatory requirements and industry standards.
  • Strong knowledge of regulatory requirements and industry standards, including GxP, ISO 13485, and FDA regulations.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.

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