Manager, Quality Assurance (GMP)

Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL locations

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 Manager Quality Assurance will report to Quality Assurance leadership and support GMP compliance related to drug substance and drug product manufacturing processes. This role will contribute to quality assurance activities ensuring compliance with applicable regulations and industry standards. The Manager will assist in inspection readiness efforts support batch review and release processes and work cross-functionally to maintain and improve quality systems.

Role and Responsibilities:

• Support the development implementation and maintenance of GMP quality systems including policies procedures and risk assessments in alignment with global health authority regulations (FDA EMA ICH etc.)
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities
• Participate in inspection readiness activities including documentation preparation and coordination for internal audits and regulatory inspections
• Assist with investigations root cause analysis risk assessments and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues
• Support internal QA batch review and release processes to ensure compliance with applicable regulations
• Review and help maintain controlled documents including Standard Operating Procedures (SOPs) to align with regulatory requirements and industry best practices
• Collaborate with cross-functional teams to achieve quality and compliance objectives
• Assist in tracking and maintaining quality metrics and performance indicators
• Perform other duties as assigned to support Quality Assurance initiatives
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in chemistry biochemistry life sciences biotechnology or a related field
• Minimum of 5 years of relevant experience in the pharmaceutical or biotechnology industry with a focus on GMP manufacturing
• Experience with biologics essential; familiarity with analytical laboratory testing is a plus
• Experience working with e-QMS systems (e.g. MasterControl TrackWise) to execute quality processes
• Understanding of GMP requirements for clinical and commercial biologics manufacturing
• Experience supporting audits and regulatory inspections is a plus
• Strong organizational skills with the ability to handle multiple projects in a fast-paced environment
• Excellent attention to detail problem-solving abilities and a strong sense of work ethic
• Effective communication and collaboration skills with the ability to work cross-functionally
• Fluency in Mandarin is a plus

The pay range for this role is $122000-$143000 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.