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Manager, Quality Assurance

Quality Control/Assurance

US-Emeryville, CA OR Remote

Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.

This position functions as the QA-designated subject-matter expert for commercial products by establishing, implementing, and maintaining all quality related activities across the company and Contract Manufacturing Organizations (CMOs).


Manages and performs QA activities related to Product compliance and operations and responsible for providing technical quality leadership.


Responsible for assurance of all aspects of product quality and oversight, timely and meaningful resolution of potential Quality issues affecting commercial products.

Responsibilities

  • All aspects of Quality activities related to company’s commercial products.
  • Review batch, testing and associated records, product deviations and change controls. Recommend batch disposition.
  • Emphasis on analytical testing records (in-process, Release, OOS, OOT, Change Control, and Stability) providing technical/scientific expertise, strategic and quality leadership. 
  • Generate annual product quality reports and summaries, and review CMO APQR reports.
  • Manage complaint handling and adverse event quality investigations and propose corrective actions.
  • Perform quality audits per audit schedules, as requested.
  • Support customer audits and regulatory inspections. May act as Quality representative.
  • Collaborate with Regulatory Affairs to assess product quality issues for regulatory impact.
  • Represent QA at CMO/collaborator/customer meetings to ensure oversight and compliance with Dynavax and regulatory standards, and quality agreements.
  • Assure resolution of compliance issues. Escalate to management when potential compliance issues exist that may impact supply chain.
  • Identify and review Quality issues, develop proposals, make decisions with input from
    QA management. Implement decisions and/or corrective actions.
  • Establish and maintain effective working relationships with internal and external key stakeholders. 
  • Maintain working knowledge of current applicable regulations and cGxP.
  • Provide Quality expertise, advice, and/or assistance, as required.
  • Maintain working environment focused on quality, fostering learning, respect, open communication, collaboration, integration and teamwork.
  • The incumbent in this position should expect to travel up to 10%.
  • Other duties as assigned.

Qualifications

  • The manager should have a BS degree and 7 years of Scientific, Operations, Manufacturing, or Quality experience in biopharmaceutical or vaccine industry

Or

  • Master’s Degree & 5 years of Scientific, Operations, Manufacturing, or Quality experience in biopharmaceutical or vaccine industry

Or 

  • Doctorate Degree & 4 years of directly related experience in biopharmaceutical or vaccine industry
  • 2 years management experience in QA/QC supporting commercial products would be desirable
  • Provide expertise in science, analytical, and risk-based evaluation of process and product quality data.
  • Knowledge of drug substance and drug product processes (unit operations) including analytical method/validations in biologics, peptide, and/or oligonucleotide chemistry.
  • Broad to in-depth knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals.
  • Experience with early and late-stage, and commercial products, including licensure. 
  • Experience with regulatory inspections and licensure, and national and international requirements.
  • Effective communicator with proven ability to communicate complex information and concepts with clarity.
  • Effective approach to problem-solving, adept negotiator, effective troubleshooter, successfully resolving issues and conflicts.
  • Proven excellent collaborator, able to establish collaborative working relationships with internal and external stakeholders; strong team-player able to work independently, with minimum supervision.
  • Strong organizational skills, able to timely drive deliverables to completion, effectively prioritize, multitask, with 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.
  • Ability to effectively prioritize and manage multiple projects and tasks.
  • Highly ethical, flexible, action- and goal-oriented; work well under pressure; and is effective in meeting tight deadlines. 
  • Ability to stand or sit for prolonged periods.
  • Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
  • Occasional travel required, as needed.
  • Full COVID-19 vaccination is required for this position.

Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.