Summit Therapeutics

Senior Director of Technical QA (GMP)

Palo Alto, CA (US) · Director

Sponsorship not specified$217k-$271kDetected 61 days ago

RecruitingClinical TrialsGMPCommunicationCollaborationMentoring

About the 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.
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.

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
Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate.
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
Establish and maintain performance metrics

Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise.
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.

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Bachelor's degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines.
Higher degree (MS, PhD, PharmD) strongly preferred
Biologics experience is essential.
Working knowledge in analytical laboratory testing is a plus.

$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.
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.

Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.