Manager QA Operations

Cambridge, Massachusetts, United States Full-time

 

Evelo Biosciences is seeking an experienced Manager of QA Operations to support our growing organization.

This is an outstanding opportunity to join a fast-paced company leveraging the previously untapped biology of the gut-body network to develop a new class of therapies that could transform the treatment of many major diseases, potentially providing profound benefits to patients and society. Evelo Biosciences is pioneering the development of therapies designed to act on the gut-body network – monoclonal microbials. Monoclonal microbials use naturally evolved pharmacology to work in the gut for effects throughout the body and comprise an entirely new class of effective, convenient and safe medicines to address the unmet needs of huge numbers of patients with serious diseases. As a member of the Evelo team, you will play a vital role in creating this new modality of medicine.

 

We are seeking a dedicated Manager QA Operations who is interested in joining a highly dynamic and intellectually challenging team. Reporting into the Head of Quality, the successful candidate will be primarily responsible for providing appropriate oversight to ensure cGMP compliance of Clinical Trial Material (CTM) and Contract Manufacturing Organizations (CMOs). The position will provide a tremendous opportunity to work in collaboration with the QA leads, CMC, Manufacturing and Regulatory teams to develop and implement programs for appropriate regulatory compliance.

Primary Responsibilities:

  • Routine management & coordination of GMP compliance systems and policies.
  • Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
  • Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
  • Assures GxP and company procedures are followed and, if needed, procedures/policies are revised.
  • Review and approve CMO Master Batch Records (MBRs) and Executed Batch Records (EBRs) to support the clinical program at Evelo Biosciences
  • Review and approve clinical packaging and labeling documents
  • Review and approve analytical methods, specifications
  • Contribute to the development and revision of the Controlled Documents System internally at Evelo Biosciences to ensure compliance with applicable FDA, EU and other regulatory agency requirements and guidance documents.
  • Review deviations, change controls and CAPAs related to investigational products
  • Support internal and external cGMP audit plans for Evelo Biosciences development programs.
  • Contribute to the development and implementation of the corporate strategy for cGMP compliance.
  • Support CMOs and Evelo Biosciences internal preparation in the overall regulatory inspection management (general GMP and GCP inspections) covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up.
  • In cooperation with CMOs and other functions within Evelo Biosciences, support the CMOs in devising and executing remediation actions to ensure compliance to regulatory and Evelo Biosciences expectations and requirements.
  • Provide guidance, advice, and support for GMP Quality Compliance matters. As a member of the CMC team, participate in the agreed projects and activities designed to support Quality aspects of CMC objectives within Evelo Biosciences.
  • Quality Metrics – participate in metrics, reporting, reviewing, and trending of cGMP-related Quality Key Performance Indicators (KPIs) in support of the QMS.
  • Perform data audits of CMC documentation intended for submission to regulatory health authorities (e.g., FDA, EMA).
  • Read and interpret new and current compliance manuals, guidance documents, and regulatory enforcement trends/actions, and disseminates information, as needed.
  • Support development of GMP training programs as needed.
  • Maintain all associated tracking logs, audit files, as applicable.

 

Desired Education/Skills/Qualifications/Experience:

  • A minimum bachelor’s degree in a scientific discipline e.g. chemistry, pharmacy, biochemistry, biology, or related discipline required
  • Minimum 5 years of QA GMP experience in the biotech/pharmaceutical environment required
  • MS in chemistry, pharmacy, biochemistry, biology, or related disciple preferred
  • Demonstrated strong understanding of US cGMPs and knowledge of EU GMPs
  • Experience in hosting GMP regulatory inspections desirable
  • Experience in the following is highly desirable:
    • Chemical drug substance operations
    • Solid oral dosage form manufacturing
    • Investigational product distribution/supply chain logistics
    • Experience with external CMO environments and as a part of a CMC team
    • Technology transfer and early phase clinical development
    • Excellent technical report writing skills
    • Strong Communication, interpersonal and problem-solving skills and detail oriented
    • Domestic and international overnight travel is required
  • Undertake domestic and international travel up to 40%.

 

 

About Evelo

Evelo Biosciences is dedicated to improving the lives of patients globally through the development of a new modality of medicines – monoclonal microbials. Monoclonal microbials are orally delivered medicines that modulate systemic immunology and biology through direct interactions with human cells in the gut. These new medicines are broadly applicable across many diseases – including autoimmune, immunoinflammatory, metabolic, neurological, neuroinflammatory diseases and cancer. Monoclonal microbials have the potential to fundamentally change traditional models of drug discovery and development. By finding and selecting naturally occurring monoclonal microbials with defined therapeutic effects, Evelo can improve the speed, cost and success of drug discovery and development. Evelo’s platform enables pharmacological intervention at all stages of disease with naturally occurring, safe and effective monoclonal microbials. Evelo Biosciences was conceived and created within VentureLabs®, Flagship Pioneering’s institutional innovation foundry, and launched by Flagship in 2015. For more information, please visit www.evelobio.com.

 

Apply for this opening at http://evelobio.recruiterbox.com/jobs/fk0fay7?apply=true