Senior Director of Technical QA (GMP)

Senior Director of Technical QA (GMP)

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)
• 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 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.

On-Site 4 days per week at our Palo Alto, CA, Princeton, NJ or Miami, FL offices

Overview of Role:

The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit's oncology pipeline. The Senior Director will serve as the primary quality interface between internal CMC Technical Operations and external manufacturing partners and will play a pivotal role in supporting clinical and commercial readiness milestones. The Sr. Director will focus on readiness for BLA filing, and PLI readiness. This position requires a seasoned quality leader capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics.

Role and Responsibilities:

• Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture.
• Collaborate with MSAT team on process development, technology transfer, scale-up activities, and other manufacturing changes and provide quality oversight and input.
• QA Lead for Process Performance Qualification (PPQ/PV), Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Computer System Validation (CSV) activities.
• Lead and ensure GMP inspection readiness activities for Summit and external CMOs and manage all regulatory inspections in collaboration with relevant stakeholders
• Mentoring other individuals within the organization in the area of compliance.
• Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions as appropriate
• Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate.
• Supervise and guide internal audits of departments and processes
• Review existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulations
• Write, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulations
• Drive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectives
• Develops a robust quality system and fosters best practices across the organization
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met.
• Establish and maintain performance metrics

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines. Higher degree (MS, PhD, PharmD) strongly preferred
• A minimum of 15 years' experience in the pharmaceutical industry with at least 8 years' experience in commercial manufacturing of drug substance and drug product.
• Biologics experience is essential. Working knowledge in analytical laboratory testing is a plus.
• Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise. Strong proficiency in CMC regulatory submissions, with direct experience reviewing IND/IMPD sections, BLA/MAA CMC modules.Strong expertise and experience with GMP manufacturing requirements for clinical and commercial biologics
• Demonstrated ability working with and managing CMOs
• Experience in designing and implementing quality systems and risk management tools
• Experience leading/hosting US and international health authority inspections
• Excellent communication skills both oral and written.
• Experience in working independently on multiple programs in a fast-paced environment with and able to balance changing priorities
• Attention to detail, self-motivated with a strong sense of work ethic
• Excellent interpersonal skills and collaborative

This is the pay for this position

Pay Transparency

$217,000 - $271,000 USD

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 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.