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Senior Manager/Associate Director, Quality Assurance

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 Senior Manager/Associate Director of Quality Assurance is responsible for all Quality Assurance aspects related to internal manufacturing at the Cambridge and Acton sites and external manufacturing at third party vendors. This position will manage and continually improve Vedanta’s existing quality management system. This position will develop and provide strategic direction in the implementation of quality policies, procedures, and infrastructure to ensure compliance with global regulatory agencies in a phase appropriate manner. Title will be commensurate with experience.

Here’s What You’ll Do:

  • Lead the QA Operations, and Records Management and Training teams in support of the Vedanta GXP Operations
  • Manage the disposition of Cell Banks, Drug Substance, Drug Product, and Finished Drug Product/Placebo
  • Review manufacturing batch records, CofAs, deviations, and change controls
  • Oversee the electronic Quality Management System (Deviations, CAPAs, Change Controls)
  • Oversee the Documentation and Training systems
  • Manage clinical material disposition at Packaging and Labeling Contract Manufacturing Sites
  • Lead the expansion of the established Quality Management System to support company goals and plans
  • Develop, coach and train personnel to ensure that adequate quality oversight and understanding is built-in to day-to-day operations
  • Identify Quality and Compliance related issues and collaborate with cross-functional teams to implement practical solutions in a strategic and proactive manner
  • Drive the use of strategies, technologies, resources, and processes in support of quality initiatives

Requirements:

  • Bachelor’s degree in a scientific discipline or a related field with 7-10+ years of industry experience
  • 3-6+ years of experience in Quality Assurance management within a biologics manufacturing setting is required
  • Prior experience with product disposition and related decision making is a key core competency
  • A proven track record of leadership, people management, and effective interpersonal and communication skills
  • Thorough knowledge of CGMP guidelines and application of phase-appropriate requirements
  • Prior experience supporting on site drug substance and/or drug product production
  • Ability to prioritize and manage complex processes/projects
  • Must have experience in smaller organizations supporting the development of novel biopharmaceutical technologies and/or products, to support creative problem solving
  • Should possess some technical knowledge of biologics manufacturing areas, with an aptitude to understand the basic science of Vedanta’s production processes

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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