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PRIMARY PURPOSE OF POSITION:

Manage and lead the activities related to developing and implementing standard operating procedures, review records, documents, and reports. As needed, the Quality Operations Manager assists the Associate Director of Quality Assurance with tasks and activities in support of QA projects and business needs.

MAJOR DUTIES OF POSITION:

Review standard operating procedures (SOPs) and, where necessary, write and/or revise SOPs that apply to quality control labs, contract testing and manufacturing operations.

Review validation documents and provide comments, as appropriate, to finalize validation protocols and reports.

Review batch records and release or reject lots.

Review stability protocols and provide guidance with respect to compliance. Where necessary, provide assistance to satisfactorily close deviations.

Manage the change control system to ensure compliance with regulations. Provide assessment of risk(s) associated with any change requests and their requirements.

Review all testing, manufacturing, and contract vendors’ related deviations. Lead investigations related to deviations for their satisfactory closure.

Review analytical and quality control documents.

Develop internal and external audit schedules and execute the audits. Provide final audit reports and perform follow-ups to open items discovered during audits.

Develop CGXP training modules in collaboration with appropriate department managers and conduct the required training.

Assess and maintain the document control system in compliance with all applicable regulations.

As requested, provide assistance with all regulatory inspections and any other audits of Dynavax facilities.

Provide Quality Assurance representation at project meetings, including PLI support.

Draft and review internal and external Quality Agreements.

Provide quality systems assessment of clinical quality and regulatory affairs functions in collaboration with the respective department managers. Implement systems for closure of identified compliance gaps.

Ensure implementation and adherence of quality compliance for technical transfer between functional groups and across sites.

Administer quality complaint system and coordinate responses with appropriate department managers.

Provide any requested information to Regulatory Affairs Department related to filings and questions from regulatory agencies.

Provide quality assistance to other departments as requested.

Travel as required to accomplish responsibilities of position.

KNOWLEDGE AND SKILL REQUIREMENTS:

BS in life sciences and at least 5 years experience in quality operations in the biotechnology or pharmaceutical industry and a minimum of 2 years supervisory experience.

Knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals.

Experience with regulatory agencies concerning inspections and questions related to submissions for product approvals.

Must have excellent communication, interpersonal and training skills.

Excellent organizational; strong analytical and problem solving skills.

Proven ability to establish collaborative working relationships; team oriented and must be able to work independently.

Excellent ability to prioritize and manage multiple projects and tasks.

Personal attributes include flexibility, integrity, action and goal oriented.

Must be willing to travel approximately 20% to support corporate initiatives.

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