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Senior Director / Vice President, Head of Quality Assurance

Cambridge, Massachusetts, United States

Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.

We are a thriving, collaborative, creative community of diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.

Delve further. Please visit www.generationbio.com or follow @generationbio.

POSITION SUMMARY:

Generation Bio seeks an energetic, versatile and highly driven leader to build the Quality Assurance function for our novel gene therapy platform. The Head of Quality Assurance will define a quality assurance strategy for Generation Bio that is aligned with company objectives. The successful candidate will lead the development and implementation of quality systems for all GxP functions to ensure compliance with applicable regulations. This is a highly visible role that is integral to the success of the company.

PRIMARY RESPONSIBILITIES:

  • Collaborate with Generation Bio leadership and key functional stakeholders in CMC, Preclinical, Clinical, IT and Regulatory to define a quality assurance strategy that is aligned with company objectives, including a clear vision for the structure and role of the Quality Assurance and Quality Control functions
  • Lead the development, implementation and continuous improvement of the company’s quality systems, including oversight of GxP training
  • Drive and cultivate a culture of Quality throughout the company
  • Build and mentor a strong team to set the quality strategy, standards, and operational plans as our products move from preclinical to clinical development
  • Ensure compliance with applicable GxP regulations, standards, policies and procedures, including quality management and audit of vendors and contract manufacturing organizations
  • Provide regular updates and recommendations to the leadership team and BOD on quality initiatives
  • Represent company with external regulatory bodies, e.g. the Food and Drug Administration (FDA) inspectorate, and other global regulatory compliance inspectors
  • Provide QA subject matter expert (SME) support for business activities
  • Define and manage Quality departmental budget and capital expenditures
  • Demonstrated ability to think strategically and interpret quality standards and regulations for a novel modality, ideally with gene therapy experience
  • Proven ability to develop a quality strategy that evolves as necessary with a growing company and adapts to changes in industry standards
  • Deep knowledge of all facets of Quality Assurance (GCP, GMP, GLP, GTP), Quality Control, Quality Systems and global regulations
  • Experience building a high-performing team and mentoring
  • Ability to anticipate and recognize ambiguous situations, and to assess risk and make decisions in uncertain situations
  • Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
  • Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
  • Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives
  • B.S. (Biology or related Life Science) with 15+ years of relevant quality assurance experience in the pharmaceutical industry
  • Prior experience in the gene therapy and/or rare disease space and with a company transition from preclinical to clinical stage

REQUIRED SKILLS:

  • Demonstrated ability to think strategically and interpret quality standards and regulations for a novel modality, ideally with gene therapy experience
  • Proven ability to develop a quality strategy that evolves as necessary with a growing company and adapts to changes in industry standards
  • Deep knowledge of all facets of Quality Assurance (GCP, GMP, GLP, GTP), Quality Control, Quality Systems and global regulations
  • Experience building a high-performing team and mentoring
  • Ability to anticipate and recognize ambiguous situations, and to assess risk and make decisions in uncertain situations
  • Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
  • Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
  • Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives

PREFERRED QUALIFICATIONS:

  • B.S. (Biology or related Life Science) with 15+ years of relevant quality assurance experience in the pharmaceutical industry
  • Prior experience in the gene therapy and/or rare disease space and with a company transition from preclinical to clinical stage

POSITION: Full-Time, Exempt

EEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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