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About Summit
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Our core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people.
Overview of Role
The Associate Director of PV Quality and Compliance will report to the Senior Director, PV Operations and Compliance and oversee Patient Safety & PV (PSPV) quality, compliance, Pharmacovigilance System Master File (PSMF) development and maintenance, and SDEA management activities. The role promotes inspection readiness and maintains a robust global compliance program within the PSPV department, leading PSPV preparation, delivery, and response to audits/inspections, supporting issue reporting and CAPA development, monitoring internal and vendor quality and compliance, overseeing SDEA compliance, developing and maintaining the PSMF, and building a training model for PSPV and cross-functional teams.
Responsibilities
- Lead development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for PSPV.
- Ensure PV processes and systems comply with global regulatory guidelines, company policies, and industry best practices.
- Develop and implement a comprehensive quality assurance strategy aligned with PSPV functional goals, including audit program and SCRAP.
- Prepare and present PV Compliance Reports to senior management.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities.
- Ensure PV system is set up for accurate adverse event reporting and periodic reports in compliance with global regulatory requirements.
- Monitor and analyze vendor and internal KPIs and KQIs to ensure effective PV processes and compliance.
- Ensure compliance with all PSPV vendor plans and Safety Data Exchange Agreements (SDEAs).
- Collaborate with cross-functional teams to address compliance issues and improve processes.
- Manage quality issues, including CAPA implementation and effectiveness reviews.
- Develop and deliver PV training programs for internal staff and external vendors.
- Participate in internal and external audits and inspections, ensuring audit readiness of all documentation.
- Provide ongoing support during inspections and develop responses to regulatory findings.
- Partner closely with PSPV, QPPV Office, and cross-functional teams to support successful and compliant execution of Summit PSPV activities.
- Actively lead the development and implementation of a call center for AE Reporting.
- Oversee case management, SDEA / PVA activities, and study related activities (SAE Reconciliation, SMP Reviews, Study Management Team Meetings, etc.).
- Undertake other activities as needed or as requested by the supervisor.
- All other duties as assigned.
Qualifications
- BS/BA in nursing, pharmacy, or life sciences.
- Minimum of 12+ years of experience in biotech, pharma, or CRO drug safety functional group, with 6+ years in PV quality assurance or compliance.
- Strong knowledge of global regulations and guidelines, GVP regulations, and industry best practices.
- Experience working with CROs, vendors, and development partners.
- Proficiency in using safety databases and software.
- Experience supporting (or leading/hosting) internal / external audits and regulatory authority inspections.
- Proficiency in MS Office 365 (Excel, Word, PowerPoint, SharePoint, Teams).
- Leadership skills to provide training, mentoring, and collaborate with cross-functional teams.
- Detail-oriented with strong analytical and problem-solving capabilities.
- Ability to multi-task and prioritize work with minimal supervision.
- Excellent interpersonal, verbal, and written communication skills.
Compensation
The pay range for this role is $186,000–$233,000 annually. The total compensation package may also include bonus, stock, benefits, and variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Summit is an equal opportunity employer. All qualified applicants, regardless of race, color, religion, national origin, sex, gender identity, sexual orientation, age, disability, veteran status, or any other characteristic protected by law, are encouraged to apply.
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