Job Description:

Associate Director, GVP Quality & Compliance

Job Location

US-CA-Emeryville

Overview

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 ourcorporate values, and these form the basis of our dynamic companyculture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Dusseldorf Germany.

The Associate Director, GVP Quality & Compliance is responsible for assisting in the development, coordination and/or implementation of Good Pharmacovigilance Practice (GVP) related quality and compliance policies, strategy, directives and procedures for Dynavax departments, and partners to help identify and proactively manage potential compliance risks.

Responsibilities

Collaborates with Clinical Quality Assurance (CQA) Leadership to establish goals and objectives for the department as a whole;
• Assist in the establishment and implementation of policies, directives and/or procedures within CQA to ensure the goal of building consistency, transparency and thoroughness in the assessment of quality within GVP related functions at Dynavax


• Continuously up to date with the latest industry changes with regulatory requirements and provides consultancy on GVP quality/regulatory related issues;


• Defines and manages the GVP Audit program ensuring audits are executed within the agree upon timelines, in compliance with SOPs, relevant agreements and applicable regulations.


• Prepares Dynavax for PV inspections, identifies risks and proposes mitigation plans


• Co-hosts and/or participates in relevant external and regulatory authority PV inspections at Dynavax


• Assist in the responses and resolutions to issues relating to external audits and regulatory inspections performed at Dynavax;


• Communicates and escalates situations of CQA corporate risk and serious compliance observations; and follows to resolution;


• Participates in the development and management of the CQA departmental budget;


• Performs other duties as requested by Management

Qualifications

• Partner with functional areas supporting GVP related activities to ensure compliance with applicable operating procedures, regulations and guidelines.


• CQA point of contact for GVP related queries.


• Review departmental procedures and documents (e.g., Safety Management Plans, SOPs, polies, partner agreements, etc.) from GVP compliance perspective.


• Contribute to the development and Maintenance of the Pharmacovigilance Master File (PSMF).


• Lead the annual audit program, developing the audit schedule and ensuring audits are conducted according to the approved schedule. Plan and/or conduct audits of PV vendors and internal systems/processes. Develop audit plans/scope, author or review audit reports, enter reports into the audit management system, review audit responses for adequacy, based on risk; track audit commitments and evaluate evidence to ensure commitments have been satisfied. If required, partner with consultants on audit activities.


• Create GVP inspection readiness program to ensure positive inspection outcomes for Dynavax.


• Co-host/participate in and support internal audits and regulatory authority inspections, as required.


• Demonstrate knowledge of applicable regulations, applying FDA, EU and ICH regulatory requirements for GVP activities.


• Independently lead non-compliance investigations, assessing the impact and risk of potential non-compliances. Generate investigation reports, determine investigation outcomes and suggest corrective and preventive actions. Communicate potential compliance risks openly and effectively across the functional areas and assist in effectively resolving them.


• Follow current regulatory enforcement trends to ensure clinical trials meet global standards. Provide feedback and updates, as applicable, to SOPs, training materials, policy changes to align with regulatory updates and business needs.


• Maintain and track SOP deviations and CAPAs, including follow-up with stakeholders on remediation activities to ensure actions are assigned, carried out and completed within committed timelines


• Serve as the CQA process owner for select CQA SOPs. Author/revise CQA SOPs to ensure they meet regulatory requirements and industry standards; assess for continuous improvement.


• Establish and GVP training program.


• Develop and generate routine quality/compliance metrics, assess for trends. Determine appropriate corrective and preventive actions and escalate trends to management. Utilize metrics to drive process improvement within CQA and functional areas supporting GVP activities.


• Build and maintain strong relationships within and across relevant functional areas (for example Quality Assurance, Drug Safety & Pharmacovigilance, Clinical Operations, Regulatory Affairs).


• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.


• Position may require up to 25% travel.


• Perform other duties as required.

KNOWLEDGE AND SKILLS REQUIRED:

• BS/BA degree in a scientific or health-rated field with 10-12 years' progressive experience in quality/compliance function with a minimum of 8 years' direct GVP quality experience are required.


• Proven experience in a quality/compliance function, with hands-on experience related to clinical trials and audits.


• Knowledge of applicable US FDA, EU and ICH regulatory requirements and guidelines as applicable to clinical research.


• Excellent written and oral communication skills.


• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.


• Ability to work independently and proactively resolve issues in a diplomatic, flexible, and constructive manner.


• Highly ethical, self-motivated and self-directed; work effectively independently as well as in a team environment.


• Proven ability to influence people at different levels of the organization.


• Experience with health authority inspections and inspection readiness activities.


• Computer skills: MS Word, Excel, PowerPoint, Microsoft Project, Visio.