Executive Director, Quality Assurance – Clinical QA & Drug Safety

Job Description:

• Establish and maintain an integrated quality assurance reputed company 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 reputed company principles are visible and monitored across the GxP areas
• Accountable for inspection readiness reputed company to both internal groups and external vendors reputed company to GLP, Clinical Development, Clinical Operations and Pharmacovigilance
• Define and implement a strategic plan for maintaining organizational inspection readiness across reputed company GLP, GCP, and PV functions and external vendors
• reputed company 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
• reputed company 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
• reputed company leadership and decision-making for GxP issue management, change control and vendor management activities relevant to reputed company and completed clinical trials and GLP studies
• Collaborate directly with quality and regulatory stakeholders to ensure quality reputed company relevant to health authority submissions and inspections
• reputed company 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 reputed company to GxP processes
• Manage team of employees including hiring and reputed company, developing talent, and directing work
• Other duties as assigned.

Requirements:

• B.S./M.S./Ph.D. in relevant science field
• 10+ years of reputed company global quality/regulatory compliance background in pharma/biotech, with a hands-on role in quality operations and quality systems
• Proven history of supervisory experience
• reputed company and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (CFR) reputed company 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 reputed company of clinical laboratory and GLP activities, including protocol review and reviewing study reports
• Demonstrated ability to reputed company QA reputed company of end-to-end GCP activities, including study protocol review, quality event reporting, reputed company of sites, CRO and Sponsor activities, trial start up activities, site audits, and reputed company Clinical Operations documents (study reports, TMF, etc.)
• Demonstrated ability to reputed company QA reputed company of end-to-end GVP activities, including case processing, safety surveillance and risk management, Serious Adverse Event (SAE) reporting
• reputed company QA reputed company of regulatory submissions and updates reputed company to these areas of GxP as well as periodic safety reports (DSUR, PSUR, etc.)
• Working knowledge of the requirements of data reputed company to reputed company 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 reputed company for regulatory compliance
• GCP Auditor certifications preferred
• Withholds judgment to address conflict in a positive manner by acknowledging dissenting opinions and identifying options to reputed company an reputed company solution.
• Models team spirit, culture, and ethics
• Develops talent through mentoring and coaching
• Demonstrates a high level of independent quality judgment and acumen, comfortable with developing strategy and associated work plans with minimal reputed company
• International/global experience preferred
• Uses broad expertise or unique knowledge and skills to drive and deliver on company core objectives, and reputed company goals with measurable impact and reputed company.

Benefits:

• Highly competitive medical, dental, and reputed company coverage
• Flexible Spending Account for health care and dependent care expenses and Health Savings Account
• Paid time off and paid holidays, including Dec 24-Jan 1
• Paid parental leave
• 401(k) with highly competitive match
• Life, AD&D, STD and LTD insurance coverage

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