Quality Assurance Manager (EU)

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• 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.

Colorectal Cancer (CRC)

• 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 Chinas 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 QA Manager 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 QA Manager will act as a key liaison between manufacturing regulatory and quality teams tomaintainproduct integrity and patient safety. This position will also oversee quality systems support product development and commercialization and ensure that all activities align with Summits 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 seamlesssupportto theQualified Person (QP) in batch certification and release activities.

• Ensuretimelyreview and approval of batch records and associated documentation.

• Act as responsible person (RP) SMEis responsible forensuring that the product is transportedstoredand delivered according to the license and in compliance with GDP addition the RPis responsible forensuring that the product is not tampered with stolen or counterfeited during distribution.

• 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 EU qualitysystem.

• Ensure compliance with EU GMP ICH guidelines HPRA and EMA regulatory requirements.

• Provide leadership on quality assurance (QA) and quality management system (QMS) SOPs and quality documentation are current and compliant.

• Deliver GMP training and supportjunior QA team members.

• Conduct audits of CMOs CDMOs and suppliers to ensure compliance with GMP standards.

• Prepare for and host regulatory inspections and internal/external audits. Implement corrective actions and continuous improvement plans.

Experience Education and Specialized Knowledge and Skills:

• BSc/MSc/PhD in Pharmaceutical Sciences Chemistry Biology or related discipline

• Minimum5 years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry

• 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 and influence in a cross-functional global team setting.

• Strong problem-solving skills and ability to manage complex quality issues remotely

• Excellent communication leadership and problem-solving skills.

Desirable:

• Experience in sterile manufacturing or biologics.

• Eligibility or aspiration to become a Qualified Person (QP).

• Experience working in a virtual BioPharma company would be desirable but not essential.

• CMO Oversight experience would also be beneficial.

What We Offer

• Competitive salary and benefits package.

• Opportunity to work in a dynamic innovative environment.

• Career development and training support.

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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.