About Us :: Careers :: USA :: Manager / Sr. Manager GLP QA
PRIMARY PURPOSE OF POSITION:
This position is responsible for all functional Quality Assurance activities in the development, implementation and maintenance of Good Laboratory Practice (GLP) activities performed by, or overseen by Dynavax Technologies. The incumbent will work with the key stakeholders in R&D and other research personnel, to assure GLP studies are performed and documented in accordance with current regulatory requirements and conducted under QA review and oversight.
The incumbent in this position is a subject matter expert who uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Manager level staff provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules.
At this level, this position is expected to work on problems of diverse scope in which analysis of situations or data requires an evaluation of identifiable factors and exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions/results. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.
MAJOR DUTIES OF POSITION:
• Review and approve all protocols, reports, and records that must comply with 21CFR58 and/or OECD GLPs on behalf of QA Department. Approve or reject studies as appropriate and issue the compliance certificates.
• Collaborate and cooperate with key stakeholders and other research staff to assure compliance in GLP activities. Provide advice and feedback regarding GLP compliance; perform internal audits as required, to assess compliance.
• Qualify external GLP laboratories and contract organizations by performing or overseeing audits, keeping a schedule, and auditing studies as required.
• Notify management of significant and/or serious compliance concerns, deviations, and gaps; propose mitigation strategies.
• Provide general GLP training and consult on GLP matters to internal staff as needed.
• Establish and maintain GLP quality metrics, to include in QA quality trend reports.
• Assist in communications with Subject Matter Experts (SMEs), Study Director, and contract laboratory organizations (CLOs), as appropriate, on quality related issues to facilitate corrections, clarifications, and resolution of associated quality issues.
• Create and refine SOPs to assure that GLP compliance is in compliance and efficient. Follow up on exceptions with appropriate CAPA and support other departments in achieving timely closure of CAPA.
• Manage quality agreements with external GLP testing laboratories.
• Compile and organize executed GLP record documentation, which includes, but is not limited to, protocol deviations, report, analytical data package, together with associated documentation.
• Develop and implement QA systems and SOPs.
• Update and maintain Quality Assurance Operations logs and databases, and generate metrics as needed.
• Coordinate and assist in the resolution of moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, or any other quality events as directed by QA management.
• Participate in internal audits and support external audits.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other duties, including GMP support, as assigned.
KNOWLEDGE AND SKILL REQUIREMENTS:
• Bachelors Degree (BA/BS), preferably life science with 4 to 8 years’ experience in GMP Quality Systems that support pharmaceutical product development and lot release.
• Must have working knowledge of 21CFR58 (GLP regulations)
• Knowledge of OECD GLP a plus.
• Auditing Certification or equivalent experience is required.
• Experience working with contract laboratory organizations is highly desirable.
• Excellent organization, communication and presentation skills are a must.
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
• Must have excellent attention to detail, time management and investigative skills as well as the ability to manage multiple priorities with aggressive timelines.
• The ideal candidate is self-motivated, and directed; is able to work independently as well as in a team environment.
• Must have knowledge of project management concepts, have the ability to adapt to changing priorities, and deliver on objectives.
• Personal attributes required include:
o Flexibility and integrity
o Goal oriented and self-starter
o Possess a practical approach to problem-solving
o Demonstrated good judgment and decision-making experience
o Collaborative
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