Senior Manager, EU Quality Assurance
Summit Therapeutics · National University of Ireland, Galway, Ireland
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:
Non-small Cell Lung Cancer (NSCLC)
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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.
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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.
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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
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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 Senior Manager, EU QA will lead and manage quality assurance activities to ensure compliance with EU GMP, regulatory requirements, and company standards. This role involves oversight of quality systems, batch release processes, audits, and continuous improvement initiatives. The person in this role will act as a key liaison between manufacturing, regulatory, and quality teams to maintain product integrity and patient safety. This position will also provide senior-level oversight of quality systems, support product development and assist in the clinical IMP QP oversite and commercialization process, and ensure that all activities align with Summit’s mission to deliver safe, effective therapies to patients.
Role and Responsibilities:
- Oversee remote batch release operations, ensuring real-time quality oversight of manufacturing and testing conducted at global contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). Manage batch documentation reviews and approvals using digital QMS platforms and electronic batch records (EBRs).
- Collaborate with CMOs, CDMOs, and supply chain partners to ensure seamless support to the Qualified Person (QP) in batch certification and release activities.
- Ensure timely review and approval of batch records and associated documentation.
- Support as the Qualified Person (QP) in the certification and release of IMP product by ensuring that relevant manufacturing, testing, supply chain, and quality documentation is complete, accurate, and available for QP certification.
- Coordinate the timely escalation and resolution of quality issues that may affect QP certification.
- Maintain and improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP and ICH guidelines.
- Oversee CAPA, change control, deviation management, and risk assessments for the EU quality system.
- Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements.
- Provide senior leadership on quality assurance (QA) and quality management system (QMS) initiatives and ensure SOPs and quality documentation are current and compliant.
- Provide quality leadership and risk-based recommendations for complex or significant quality issues, including appropriate escalation to Quality leadership.
- Lead cross-functional quality activities and represent EU Quality in relevant project, governance, and operational forums.
- Deliver GMP training and mentor and support junior QA team members.
- Conduct audits of CMOs, CDMOs, and suppliers to ensure compliance with GMP standards and provide oversight of audit follow-up and remediation activities.
- Prepare for and host regulatory inspections and internal/external audits. Lead or oversee corrective actions and continuous improvement plans.
- Support the ongoing development and continuous improvement of the EU Quality function, including quality metrics, inspection readiness, and harmonisation of quality processes.
Experience, Education and Specialized Knowledge and Skills:
- BSc/MSc/PhD in Pharmaceutical Sciences, Chemistry, Biology, or a related discipline.
- Minimum 6+ years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry, with demonstrated experience leading quality activities.
- Experience in remote batch release, electronic batch records (EBRs), and digital QMS systems.
- Strong knowledge of good distribution practices (GDP), with an RP background.
- Strong knowledge of EU regulatory requirements, HPRA/EMA expectations, and GMP compliance for global supply chains.
- Experience in managing audits and regulatory inspections.
- Experience working with CMOs/CDMOs and managing outsourced manufacturing.
- Proven ability to lead, influence, and make sound risk-based decisions in a cross-functional, global team setting.
- Strong problem-solving skills and ability to manage and escalate complex quality issues remotely.
- Excellent communication, leadership, mentoring, and stakeholder-management skills.
Desirable:
- Experience in sterile manufacturing or biologics.
- Experience working in a virtual BioPharma company would be desirable but not essential.
- CMO oversight experience would also be beneficial.
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.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.