Executive Director of Quality Assurance and Compliance

2 months ago


Waltham, Massachusetts, United States Lifelancer Full time
Lead a Team in Ensuring Regulatory Compliance

We are seeking an experienced Executive Director of Quality Assurance and Compliance to lead our quality team in ensuring regulatory compliance across all aspects of our operations.

About the Role:
  • Develop and implement a comprehensive quality strategy that aligns with our commercialization goals and global regulatory standards.
  • Oversee the establishment, maintenance, and continuous improvement of commercial-stage quality systems, driving operational excellence and risk management practices.
  • Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors, ensuring audit readiness and seamless inspections.
  • Cross-functionally collaborate with Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, and other key teams to embed quality into each phase of the development and commercialization process.

In this role, you will be responsible for leading a high-performing QA team to ensure a culture of quality across the organization. You will provide guidance, training, and development to keep the team up-to-date with evolving quality and regulatory standards.

Requirements:
  • Bachelor's degree in Life Sciences or a related field; advanced degree desirable but not required.
  • Minimum of 12 years' experience in the pharmaceutical or biotech industry in a quality or related role, with 5+ years in a commercial-stage role.
  • Experience in oncology or other high-impact therapeutic areas.
  • Demonstrated success managing quality and regulatory compliance in a global environment.
  • Excellent verbal and written communication skills, with a proven track record of engaging and influencing internal and external stakeholders, including regulatory agencies.

The ideal candidate will have a strong understanding of GxP knowledge and relevant global regulatory requirements, with expertise in developing and leading quality strategies and organizations. They will possess leadership abilities, analytical and problem-solving skills, and hands-on experience with implementing and managing Quality Systems and process infrastructure.

Salary Range:

$140,000 - $180,000 per year, depending on experience.

About Us:

Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.



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