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Quality Assurance Validation Manager

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

The QA Validation Manager will be responsible for the management and continuous improvement of a compliant validation program at Vedanta, including the implementation of new equipment and the requalification of existing equipment per the equipment lifecycle program, as well as supporting validation activities for cleaning processes, facilities, utilities, and computer systems. The individual will be responsible for Quality oversight of qualification and validation of a new cGMP manufacturing facility and related equipment.

Here’s What You’ll Do:

  • Maintain Validation Master Plan for Vedanta.
  • Maintain the Equipment Lifecycle Program.
  • Manage the validation program including performance of impact assessments, risk assessments for validation, FUSE URS procedures and forms.
  • Review and approve specifications and protocols for FUSE as required.
  • Support cleaning validation activities utilized in current and future processes.
  • Oversee area qualification, warehouse mapping, and project timelines for new GMP production area(s).
  • Review and approve Master Equipment Files, CGMP equipment, and utilities IOQ protocols and reports.
  • Own equipment-related deviations, CAPAs, and Change Controls
  • Provide QA Validation support for site master file and other regulatory filings.

Requirements:

  • Bachelor’s degree in a scientific discipline, engineering, or a related field.
  • 10-12 years of experience in Validation, Quality Assurance, or a technical support role.
  • Strong communication and technical writing skills. Prior validation experience and authoring validation documents is a must. Experience managing and writing deviations, CAPA, and change control is preferred.
  • Solid understanding of relevant FDA/EMA/ICH validation requirements.
  • Experience with Veeva Vault QMS or similar software.
  • Strong leadership, organizational, and problem solving skills.
  • Flexibility to take on other duties as assigned.
  • Ability to work in a fast-paced setting and adjust to a changing environment.
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