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Vice President of Quality

1 week ago


Boston, United States Green Life Science Full time

Position Overview:

The Vice President of Quality will lead the development, implementation, and oversight of a comprehensive Quality Assurance (QA) strategy to ensure compliance with the highest global standards across clinical, regulatory, and manufacturing operations. As the primary Quality leader, this role will ensure that all products, processes, and systems meet regulatory requirements, corporate objectives, and industry best practices.


This dynamic leader will oversee all aspects of the Company’s QA function, GxP compliance, and Quality Control (QC) for products and activities. Responsibilities include establishing a robust Quality Management System (QMS), implementing quality plans and policies, and regularly reporting on compliance activities and findings. The VP-QA will design, implement, and maintain QA, QC, and compliance programs, including systems for training and GxP audits.


Reporting to the Senior Vice President of Global Regulatory Affairs and Quality Assurance, this role will act as an in-house advocate for GxP compliance and ensure the effectiveness of quality programs in a global regulatory environment.


Qualifications:

Education:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).

Experience:

  • At least 15 years of experience in Quality Assurance, including 5+ years in senior leadership within the pharmaceutical, biotech, or medical device sectors.
  • Proven expertise in developing and implementing global QA strategies.
  • Comprehensive knowledge of GCP, GMP, GLP, and international regulatory requirements.

Leadership Skills:

  • Strong ability to influence and lead cross-functional teams.
  • Diplomatic and pragmatic approach to problem-solving.
  • Demonstrated success in developing and mentoring high-performing global teams.

Technical Skills:

  • Extensive experience with regulatory inspections and audits.
  • Strong analytical and problem-solving abilities, with a proactive and results-driven mindset.
  • In-depth understanding of GMP, ICH/GCP, and FDA regulatory requirements; APAC experience is an advantage.
  • Familiarity with discovery data integrity policies and quality assurance.
  • Expertise in QA, continuous improvement, and industry best practices.

Personal Attributes:

  • Strong ethical standards, honesty, and collaborative mindset.
  • Effective communication, influencing, and negotiation skills to secure management support for initiatives.
  • Ability to manage multiple priorities in a fast-paced environment.
  • A commitment to fostering partnerships within project teams and maintaining quality standards.