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PRIMARY PURPOSE OF POSITION:

Act as the QA designated subject matter expert for commercial product(s). Coordinate and/or perform QA activities related to commercial product(s) compliance and operations. Duties will include but are not limited to assurance of commercial product quality, oversight of exceptions, and assuring timely and meaningful resolution of potential quality issues that affect the commercial product(s). This position is located at the Berkeley Dynavax site, and will involve up to 20% travel.

This position may propose operational objectives and assignments which are approved by senior management. The job holder may participate in developing, improving, and executing company policies that affect immediate operations(s) and may also have companywide effect. This level position works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. At the senior manager level, the incumbent will exercise judgment within broadly defined practices and policies in proposing methods, techniques and evaluation criteria for obtaining results.

Decisions made at this level may impact project timelines and/or affect compliance risk.

MAJOR DUTIES OF POSITION:

Manage the quality activities related to the Company’s commercial product(s) including preparing the annual product quality report.

Maintain knowledge of commercial product – from product history to current.

Review batch records and recommend batch disposition as required.

Convenes the Materials Review Board as needed for commercial product quality issues. Identifies, review quality issues, develop proposals and decides with input from QA management. Implement decisions and/or corrective actions, etc., that concern the commercial product(s).

Establish and maintain effective working relationship with key stakeholders both internal and external.

Review all exceptions or concerns involving commercial product(s), including but not limited to regulatory inspections, complaints, adverse events, non-conforming products, etc. Make appropriate notification to senior management, and propose remedies.

Work closely with Regulatory Affairs to assess changes and exceptions for regulatory impact, and to assure appropriate notification to regulators occurs.

Stay abreast of current regulatory trends and changes.

Work with the key stakeholders to assure resolution of compliance issues;

Notify management when significant potential exists for serious compliance issue to impact the supply chain.

Support the Quality team during regulatory inspections related to commercial product(s). Provide guidance to the Dynavax team, act as QA product representative during regulatory inspections.

Represent Quality Assurance at meetings and assure compliance of approved quality agreements with CMOs. May propose changes to quality agreements as needed.

Oversee outsourced commercial product complaints.

Coordinate with production, Quality Control, and other departments to ensure quality compliance and operations at all times.

Provide quality expertise, advice, and/or assistance across the organization as required.

Maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

BS degree in life sciences, bioengineering, or related field and 8 years of experience in biopharmaceutical or vaccine industry, with 2 years experience in QA/QC supporting commercial product(s).

Knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals.

Experience with 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 abilities to communicate complex information and concepts with clarity.

Should possess a flexible approach to problem-solving, be an adept negotiator, and be able to trouble-shoot.

Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team-orientation and the ability to work independently.

Ability to effectively prioritize and manage multiple projects and tasks.

The ideal candidate is highly ethical, flexible, action- and goal- oriented; works well under pressure, and is effective in meeting tight deadlines.