Title: Director, Clinical Quality Assurance
Location: Redwood City,CA
Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity
Our direct client is seeking a Director, Clinical Quality Assurance to join their Clinical Quality team.
- Provide expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation.
- Work with internal R&D functions and external parties including development partners, consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs.
- Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP and company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
- Support of a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions and enable teams to be inspection ready.
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to clinical development program teams.
- Assume complex assignments on issues or studies where there is no precedent.
- Develop and implement risk-based GCP audit and compliance strategy. Audits require advanced auditing skills and involve technically complex assignments including GCP audits and GCLP areas as needed. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Lead investigations into significant quality issues, suspected scientific misconduct and suspected serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
- In collaboration with the head of QA, facilitate GCP regulatory inspections; provide GCP compliance technical support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
- Analyze, report, and present metrics to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
- Identify and mitigate GCP quality and compliance issues with potential impact across multiple programs or functional groups.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.
- Participate in due diligence activities and process improvement initiatives as requested by management.
- May act as supervisor for full-time employees, temporary contractors, and/or external consulting partners as well as advisors to Clinical Operations and PV activities.
- Minimum of 15 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on GCP Quality Assurance experience.
- Operational experience (e.g., Clinical Operations, Data Management, etc.) an advantage.
- Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development including GVP.
- Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity, and the clinical programs.
- Experience preparing for and participating in GCP regulatory inspections.
- Strong technical writing skills; ability to write clear quality position statements, risk-based audit reports, and procedures.
- Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.
- Strong judgment, project management and decision-making skills; able to manage teams, multiple projects and demanding timelines.
- Ability to rapidly synthesize complex issues and identify risks in a pragmatic way.
- Extensive experience in building GCP systems and processes.
- BA/BS degree required; advanced degree preferred