Dynavax Technologies

Manager/Senior Manager, Commercial & Development Quality Assurance

US-CA-Berkeley
1 week ago
ID
17-039N
Category
Quality Control/Assurance

Overview

This position will function as the QA-designated subject matter expert (SME) for development and commercial products. Perform and/or manage QA activities related to development and commercial product compliance and operations.

Duties will include: Assurance of development and commercial product quality, oversight of changes, exceptions, product disposition, audits/inspections, complaints and timely and meaningful resolution of potential Quality issues.

Responsibilities

  • Perform and/or manage the Quality activities related to the company’s development (pre-clinical and Phase I-III) and commercial products, including contributing to the preparation of the annual product quality report.
  • Maintain knowledge of development and commercial product, from product history to current.
  • Review product batch records and related documentation, and recommend batch disposition.
  • Review and approve SOPs (including authoring), specifications, CoA’s, CoC’s and validation/ stability/ labeling/ packaging documents and related studies, as requested.
  • Identify and review Quality issues, develop proposals and make informed decisions with input from QA management. Implement decisions and/or corrective actions, etc. concerning development and commercial products.
  • Review deviations and/or concerns involving development and commercial products, including, but not limited to, non-conforming products, complaints, regulatory inspections, etc. Notify manager appropriately and propose feasible solution (CAPA’s).
  • Work closely with Regulatory Affairs to assess changes and exceptions for regulatory impact, and to assure appropriate notification to regulators.
  • Manage and perform assigned audit activities related to development and commercial product, including CMOs, CTLs, key raw materials (e.g., stoppers, syringes), etc.
  • Support and provide guidance to the company team during regulatory inspections related to development and commercial products. May act as QA product representative during regulatory inspections.
  • Establish and maintain effective working relationships with key stakeholders, both internal (QC, Technical Operations, Analytical development, etc.) and external, to ensure Quality compliance and operations at all times. Work with the key stakeholders to assure resolution of compliance issues. Represent QA at meetings.
  •  Stay abreast of current regulatory trends and changes, including GLP and GMP.

  • Notify management when significant potential compliance issues exist that may impact the supply chain.
  •   Assure compliance of agreements with CMOs and CTLs, specifically, compliance with both company and regulatory standards. Manage CMO’s and CTL’s to ensure compliance with the terms of agreements.

  • Provide Quality expertise, advice, and/or assistance across the organization, as required.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration and teamwork.
  • The incumbent in this position should expect to travel up to 20%.
  • Other duties as assigned.

Qualifications

  • The Manager will have a BS degree in life sciences, bioengineering, or related field with 3 to 5 years of quality experience in biopharmaceutical or vaccine industry, plus 1 year management experience in QA/QC supporting development and/or commercial products.
  • The Senior Manager will have a BS degree in life sciences, bioengineering, or related field and 5+ years of quality experience in biopharmaceutical or vaccine industry, plus 2 years’ management experience in QA/QC supporting development and/or commercial products.
  • Broad to in-depth knowledge of FDA regulatory requirements for biologics, especially pharmaceuticals or vaccines. Solid knowledge of GLP and GMP.
  • Experience with early and late-stage products, including licensure and commercial stage.
  • Experience with regulatory inspections and licensure, as well as national and international requirements.
  • Must be an effective communicator with proven ability to communicate complex information and concepts with clarity.
  • Should possess a flexible approach to problem-solving, be an adept negotiator, and be effective at trouble-shooting of problems, issues and/or conflicts.
  • Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team orientation and the ability to work independently.
  • Strong organizational skills, with the ability to effectively prioritize, manage multiple projects and tasks, and have great attention to detail.
  • The ideal candidate is highly ethical, flexible, action- and goal- oriented; works well under pressure; and is effective in meeting tight deadlines.

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