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Vice President of Quality Assurance

2 months ago

Indiana, Pennsylvania, United States Rbw Consulting Full time
Position Overview
The Vice President of Quality Assurance will play a pivotal role in overseeing the quality operations within a leading Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectable and high-potency products. This role encompasses global responsibilities, ensuring compliance with Good Manufacturing Practices (GMP) across multiple facilities.

Company Background
Our client is a forward-thinking CDMO with a rich history of over 60 years in the pharmaceutical industry. With substantial investment backing, they are poised for significant growth and expansion in the coming years. The organization is committed to sustainability and community engagement, regularly organizing initiatives that positively impact the environment and local communities.

Key Responsibilities
  • Oversee the quality strategy and operational compliance for facilities in both the United States and Europe.
  • Maintain awareness of global regulatory changes that may affect business operations.
  • Establish a comprehensive surveillance process for identifying deficiencies and trends in the regulatory landscape.
  • Ensure that all Drug Master Files are current and collaborate with clients on their submissions.
  • Manage communications with regulatory bodies, including but not limited to the FDA, EMA, and other international agencies.
  • Conduct internal corporate audits focused on quality and compliance.
  • Collaborate with Product Development teams to manage regulatory filings and submissions.
  • Assist in drafting and reviewing responses to regulatory audits.

Qualifications
The ideal candidate will possess a solid understanding of aseptic practices, clean room operations, and auditing methodologies. This role requires a strategic thinker with a proven track record in quality management within the pharmaceutical sector.