Vice President of Quality Assurance

4 days ago


San Diego, California, United States Atlas Venture Full time
Job Title: Vice President of Quality

At Kailera Therapeutics, we are seeking a highly experienced and skilled Vice President of Quality to join our team. As a key member of our leadership team, you will be responsible for developing, leading, and overseeing our quality organization, ensuring compliance with international regulatory standards and driving quality initiatives to support our strategic goals.

Key Responsibilities:
  • Establish and implement the strategic quality vision, including the Quality Management Systems.
  • Oversee the design, implementation, and maintenance of GxP programs and frameworks, including QMS maintenance, SOPs, training programs, issue management, and internal and external audits.
  • Lead coordination with regulatory agencies and other external auditors to build trust and confidence in our quality systems and processes.
  • Develop, execute, and maintain risk-based audit strategies to ensure compliance with applicable regulations, ICH/GCP guidelines, and procedures.
  • Supervise and manage a team of quality professionals to ensure the effective implementation of quality systems and processes.
Requirements:
  • Bachelor's degree in Science or a related field; advanced degree desirable but not required.
  • Minimum of 15 years' experience in the pharmaceutical or biotechnology industry in a quality or related field.
  • Strong GxP knowledge and understanding of relevant regulatory requirements.
  • Hands-on experience with implementing and managing Quality systems and processes infrastructure.
  • Proven record of developing and maintaining successful working relationships with Sponsors and regulatory agencies.
What We Offer:
  • Competitive salary range: $245,000 - $320,000 USD.
  • Opportunity to work in a hybrid work environment in either our San Diego, CA or Waltham, MA office.
  • Commitment to fostering an inclusive culture and promoting diversity, equity, and inclusion.

Kailera Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.



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