Summit Corporation
Director, PV Quality & Compliance
Summit Corporation, Menlo Park, California, United States, 94029
Summary
Title:
Director, PV Quality & Compliance
Department:
Patient Safety & PV
Date Posted:
12/7/2025
About Summit Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.
At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality.
Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology.
Summit has multiple global Phase 3 clinical studies, including:
Phase 3 Clinical Studies
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi‑3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first‑line metastatic NSCLC.
HARMONi‑7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic NSCLC.
HARMONi‑GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role The Associate Director of PV Quality and Compliance will report to the Senior Director, PV Operations and Compliance and is responsible for oversight of Patient Safety & PV (PSPV) quality, compliance, Pharmacovigilance System Master File (PSMF) development and maintenance, and SDEA management activities.
This role promotes inspection readiness and maintains a robust global compliance program within the PSPV department.
The position will lead PSPV’s preparation, delivery, and response to audits/inspections, support issue reporting and CAPA development, oversee internal and vendor quality and compliance, oversee SDEA compliance, develop and maintain the PSMF, and build a training model for PSPV and cross‑functional teams.
Key operational activities include:
Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)
Protocol deviation, CAPA, and PV Training management
Communication with internal and external stakeholders
Subject Matter Expert in audits and inspections with PV scope
Support day‑to‑day PV Operational activities as needed
Role and Responsibilities
Oversight and Leadership
Lead the development, review, and maintenance of SOPs / WIs for PSPV.
Ensure PV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and SDEA standards.
Develop and implement a comprehensive quality assurance strategy aligned with PSPV functional goals; including the development, maintenance, and execution of the PSPV Audit Plan and audit program in collaboration with R&D Quality Assurance.
Prepare and present PV Compliance Reports to senior management, highlighting trends, issues, and opportunities for improvement.
Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities.
Regulatory & Safety Reporting
Ensure PV system is set up for accurate reporting of adverse events and periodic reports in compliance with global regulatory requirements.
Monitor and analyze vendor and internal key performance indicators (KPIs) and key quality indicators (KQIs) to ensure effective PV processes and compliance.
Ensure compliance with all PSPV vendor plans, and Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs).
Monitor global regulatory intelligence and surveillance activities for emerging regulations that may impact the PV system.
Quality Management & Compliance
Collaborate with cross‑functional teams to address compliance issues and improve processes.
Manage quality issues, including CAPA implementation and effectiveness reviews, impacting PSPV.
Training & Development
Develop and deliver PV training programs for internal staff and external vendors.
Update training content based on new regulatory requirements and industry best practices.
Monitor training effectiveness and make improvements as needed.
Inspection Readiness
Participate as the key PSPV stakeholder in internal and external audits and inspections, ensuring accuracy and audit‑inspector readiness of all documentation, including participation in all mock audit/inspection activities.
Provide ongoing support during inspections, ensuring PSPV teams and subject matter experts are prepared.
Provide strategic input in the development of responses to regulatory authority inspection findings and/or audit findings of Summit’s PV system.
Post‑Market / PSMF Development and Maintenance
Partner closely with members of PSPV, QPPV Office, and cross‑functional teams to support the successful and compliant execution of Summit PSPV activities.
Participate in the development and maintenance (including audits) of Summit’s PSMF.
Actively lead the development and implementation of a call center for AE Reporting.
Day‑to‑Day Case Management / PV Operations Oversight
As needed, review the Safety mailbox and address PV Operations related emails.
As needed, 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.
Experience, Education and Specialized Knowledge and Skills
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+ of those years in a PV quality assurance or compliance role.
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, and developing responses to regulatory authority inspection findings.
Proficiency in MS Office 365 (Excel, Word, PowerPoint, SharePoint, Teams, etc.).
Leadership skills to provide training, mentoring, and collaborating 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.
The pay range for this role is $186,000-$233,000 annually.
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
This may be different in other locations due to differences in the cost of labor.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable 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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
For more information on a position, click on the job title.
#J-18808-Ljbffr
Director, PV Quality & Compliance
Department:
Patient Safety & PV
Date Posted:
12/7/2025
About Summit Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.
At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality.
Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology.
Summit has multiple global Phase 3 clinical studies, including:
Phase 3 Clinical Studies
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi‑3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first‑line metastatic NSCLC.
HARMONi‑7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic NSCLC.
HARMONi‑GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role The Associate Director of PV Quality and Compliance will report to the Senior Director, PV Operations and Compliance and is responsible for oversight of Patient Safety & PV (PSPV) quality, compliance, Pharmacovigilance System Master File (PSMF) development and maintenance, and SDEA management activities.
This role promotes inspection readiness and maintains a robust global compliance program within the PSPV department.
The position will lead PSPV’s preparation, delivery, and response to audits/inspections, support issue reporting and CAPA development, oversee internal and vendor quality and compliance, oversee SDEA compliance, develop and maintain the PSMF, and build a training model for PSPV and cross‑functional teams.
Key operational activities include:
Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)
Protocol deviation, CAPA, and PV Training management
Communication with internal and external stakeholders
Subject Matter Expert in audits and inspections with PV scope
Support day‑to‑day PV Operational activities as needed
Role and Responsibilities
Oversight and Leadership
Lead the development, review, and maintenance of SOPs / WIs for PSPV.
Ensure PV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and SDEA standards.
Develop and implement a comprehensive quality assurance strategy aligned with PSPV functional goals; including the development, maintenance, and execution of the PSPV Audit Plan and audit program in collaboration with R&D Quality Assurance.
Prepare and present PV Compliance Reports to senior management, highlighting trends, issues, and opportunities for improvement.
Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities.
Regulatory & Safety Reporting
Ensure PV system is set up for accurate reporting of adverse events and periodic reports in compliance with global regulatory requirements.
Monitor and analyze vendor and internal key performance indicators (KPIs) and key quality indicators (KQIs) to ensure effective PV processes and compliance.
Ensure compliance with all PSPV vendor plans, and Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs).
Monitor global regulatory intelligence and surveillance activities for emerging regulations that may impact the PV system.
Quality Management & Compliance
Collaborate with cross‑functional teams to address compliance issues and improve processes.
Manage quality issues, including CAPA implementation and effectiveness reviews, impacting PSPV.
Training & Development
Develop and deliver PV training programs for internal staff and external vendors.
Update training content based on new regulatory requirements and industry best practices.
Monitor training effectiveness and make improvements as needed.
Inspection Readiness
Participate as the key PSPV stakeholder in internal and external audits and inspections, ensuring accuracy and audit‑inspector readiness of all documentation, including participation in all mock audit/inspection activities.
Provide ongoing support during inspections, ensuring PSPV teams and subject matter experts are prepared.
Provide strategic input in the development of responses to regulatory authority inspection findings and/or audit findings of Summit’s PV system.
Post‑Market / PSMF Development and Maintenance
Partner closely with members of PSPV, QPPV Office, and cross‑functional teams to support the successful and compliant execution of Summit PSPV activities.
Participate in the development and maintenance (including audits) of Summit’s PSMF.
Actively lead the development and implementation of a call center for AE Reporting.
Day‑to‑Day Case Management / PV Operations Oversight
As needed, review the Safety mailbox and address PV Operations related emails.
As needed, 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.
Experience, Education and Specialized Knowledge and Skills
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+ of those years in a PV quality assurance or compliance role.
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, and developing responses to regulatory authority inspection findings.
Proficiency in MS Office 365 (Excel, Word, PowerPoint, SharePoint, Teams, etc.).
Leadership skills to provide training, mentoring, and collaborating 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.
The pay range for this role is $186,000-$233,000 annually.
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
This may be different in other locations due to differences in the cost of labor.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable 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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
For more information on a position, click on the job title.
#J-18808-Ljbffr