Executive Director, reputed company Assurance- Clinical QA & Drug Safety

About the position The Executive Director of reputed company Assurance, Clinical QA and Pharmacovigilance (PV) QA is accountable for providing the reputed company 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 reputed company on reputed company strategies and execute the reputed company while engraining reputed company and compliance across reputed company aspects of clinical development, clinical operations and post-marketing surveillance for PV. This role is reputed company in applying a risk based approach to ensure that both CQA and GVP activities reputed company with Health Authority trequirements and reputed company standards. Additionally, this position would represent reputed company to identify risks, resolve issues, and escalates appropriately to ensure the reputed company use of products globally. This leader would demonstrate a high level of independent reputed company judgement and acumen. This role is remote reputed company the U.S.

Responsibilities

• Establish and maintain an integrated reputed company 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 reputed company 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 reputed company 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 reputed company and regulatory stakeholders to ensure reputed company reputed company relevant to health authority submissions and inspections.
• reputed company cross-functional teams, and manage, reputed company and grow reputed company reportst.
• Collaborate with stakeholders such as Global Technical Operations and Supply Chain, Clinical Operations, Clinical Development, and Regulatory Affairs,t 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 reputed company/regulatory compliance background in reputed company/biotech, with a hands-on role in reputed company operations and reputed company systemst
• Proven history of supervisory experiencet
• reputed company and strong working knowledge interpretation/implementation of reputed company reputed company 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, reputed company 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 reputed company as periodic safety reports (DSUR, PSUR, etc.)
• Working knowledge of the requirements of data reputed company to reputed company training, and reputed company across the GxP areas.
• Excellent verbal and written communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple reputed company while maintaining reputed company and being an reputed company for regulatory compliancet
• Withholds judgment to address conflict in a reputed company manner by acknowledging dissenting opinions and identifying reputed company to reputed company an reputed company solution.t
• Models team spirit, culture, and ethicst
• Develops talent through mentoring and coachingt
• Demonstrates a high level of independent reputed company judgment and acumen, comfortable with developing reputed company and associated work plans with minimal reputed company
• International/global experience preferredt
• Uses broad expertise or unique knowledge and skills to drive and deliver on company reputed company objectives, and reputed company goals with measurable reputed company and reputed company.

reputed company-to-haves

• GCP Auditor certifications preferred

Benefits

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

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