Summit Therapeutics

Summit Therapeutics

Senior Manager of Technical QA (GMP)

Palo Alto, CA (US) · Senior

Sponsorship not specified$158k-$185kDetected 31 days ago
Product ManagementRecruitingClinical TrialsGMPFDA RegulatoryLeadershipCommunicationCollaboration

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

4 transfer filings in the last year, covering 4 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Senior Manager of Technical QA (GMP) reports to the Senior Director of Technical QA (GMP) and provides comprehensive GMP quality oversight across the product lifecycle for Summit's oncology portfolio.
  • The position requires a seasoned quality manager capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics.

Responsibilities

  • Responsible for providing sponsor oversight of clinical Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTLs) to support clinical manufacture and testing.
  • Responsible for providing sponsor oversight of Contract Testing Laboratories (CTLs) support clinical and commercial product testing, methods, method transfers, method validations, stability, and specifications.
  • Partner with Supplier Quality to monitor quality performance metrics for CMOs, CTLs and critical suppliers, ensuring effective management of quality risks and continuous improvement initiatives.
  • Collaborate with MSAT and Technical Operations teams for Change Controls of process development, technology transfer, scale-up activities, and other manufacturing and analytical changes and provide quality oversight for the Change Control program while ensuring appropriate impact assessments, risk evaluations, implementation plans and effectiveness verification.
  • Schedule and lead weekly Change Control meetings.
  • Review existing policies and procedures, and develop new and enhanced policies that ensure compliance with 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
  • Drive continuous improvement of the Quality Management System and promote best practices across the organization.
  • Develop and monitor key quality metrics and trends to proactively identify compliance risks and drive continuous improvement.

Requirements

  • Working knowledge in analytical laboratory testing is required.
  • Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise.
  • A 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 biologics
  • 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.

Nice to have

  • Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.
  • 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)
  • 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.
  • 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)
  • Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Compensation

  • $158,000 - $185,000 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.
  • Maintain the Annual Product Quality Review process, including trend analysis, product quality assessments, process performance evaluation and management review reporting.

Benefits

  • Support GMP inspection readiness activities for Summit and external manufacturing partners and provide quality leadership during health authority inspections, supplier audits, and regulatory interactions.
  • Experience, Education and Specialized Knowledge and Skills
  • Experience supporting US and international health authority inspections

Company info

  • Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Equal opportunity

  • Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

Visa & Work Authorization

  • Responsible for providing sponsor oversight of clinical Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTLs) to support clinical manufacture and testing
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.