Executive Director, Quality Assurance- Clinical QA & Drug Safety

Role Overview The Executive Director of Quality Assurance, Clinical QA and Pharmacovigilance (PV) QA is accountable for providing the strategy and direction for Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) by partnering with the respective leaders of Clinical Development, Clinical Operations and Pharmacovigilance (PV) to align on the company strategies and execute the strategy while engraining quality and compliance across all aspects of clinical development, clinical operations and post-marketing surveillance for PV. This role is instrumental in applying a risk based approach to ensure that both CQA and GVP activities align with Health Authority requirements and our company standards. Additionally, this position would represent Quality to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally. This leader would demonstrate a high level of independent quality judgement and acumen. This role is remote within the U.S. Core Responsibilities

• Establish and maintain an integrated quality assurance oversight program for GLP, GCP and GVP areas that engrain the GxP requirements and are compliant with Health Authorities and industry standards.
• Accountable for ensuring data integrity principles are visible and monitored across the GxP areas.
• Accountable for inspection readiness related to both internal groups and external vendors related to GLP, Clinical Development, Clinical Operations and Pharmacovigilance.
• Define and implement a strategic plan for maintaining organizational inspection readiness across all GLP, GCP, and PV functions and external vendors.
• Provide QA leadership and Subject Matter Expertise (SME) for the GCP and GVP teams so that there is alignment on execution of work and compliance standards.
• Provide updates to our policies, procedures and practices based on quality and regulatory intelligence from Health Authorities, Regulators and Industry. Implement changes using a risk based approach.
• Implement a risk based approach to PV activities, defining appropriate metrics and trending.
• Provide leadership and decision-making for GxP issue management, change control and vendor management activities relevant to current and completed clinical trials and GLP studies.
• Collaborate directly with quality and regulatory stakeholders to ensure quality oversight relevant to health authority submissions and inspections.
• Lead cross-functional teams, and manage, coach and grow direct reports .
• Collaborate with stakeholders such as Global Technical Operations and Supply Chain, Clinical Operations, Clinical Development, and Regulatory Affairs, to ensure inspection preparedness, conduct compliance assessments, identify and mitigate compliance gaps, and offer guidance related to GxP processes.
• Manage team of employees including hiring and onboarding, developing talent, and directing work
• Other duties as assigned.

Required Qualifications

• B.S./M.S./Ph.D. in relevant science field
• 10+ years of progressive global quality/regulatory compliance background in pharma/biotech, with a hands-on role in quality operations and quality systems
• Proven history of supervisory experience
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (CFR) related to GLP, GCP and GVP, ICH Guidelines, and Health Authority requirement. Experience with GMP preferred.
• Experience in the biotech or pharmaceutical industry managing Health Authorities during inspections and managing Customer/Business Partners during inspections is required.
• Experience with QA oversight of clinical laboratory and GLP activities, including protocol review and reviewing study reports.
• Demonstrated ability to provide QA oversight of end-to-end GCP activities, including study protocol review, quality event reporting, oversight of sites, CRO and Sponsor activities, trial start up activities, site audits, and related Clinical Operations documents (study reports, TMF, etc.)
• Demonstrated ability to provide QA oversight of end-to-end GVP activities, including case processing, safety surveillance and risk management, Serious Adverse Event (SAE) reporting.
• Provide QA oversight of regulatory submissions and updates related to these areas of GxP as well as periodic safety reports (DSUR, PSUR, etc.)
• Working knowledge of the requirements of data integrity to provide training, and integrate across the GxP areas.
• Excellent verbal and written communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance
• GCP Auditor certifications preferred
• Withholds judgment to address conflict in a positive manner by acknowledging dissenting opinions and identifying options to achieve an equitable solution.
• Models team spirit, culture, and ethics
• Develops

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