Summit Therapeutics
Manager, Quality Assurance
Princeton, NJ · Senior
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About the role
- The Manager of QA reports to the Director of QA and will provide quality oversight for the Product Complaint program.
- This will include investigation resolution for complaints associated with clinical and commercial material.
Responsibilities
- Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints.
- Support product compliant reconciliation with the call center and Pharmacovigilance.
- Provide support for the initial review, periodic review, and revision of Summit QTAs.
- Write, revise, review and/or approve SOPs and other controlled documents.
- Support GMP inspection readiness activities.
Requirements
- 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.
Skills
- Bachelor's degree in chemistry, biochemistry, biotechnology, or other related life science discipline.
- Minimum of 5+ years of relevant experience.
- Experience managing product complaints.
- Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/ GDP regulations governing clinical and commercial biologics.
- Experience serving as an auditor in both internal and external audits.
- Experience reviewing and approving QTAs.
- Experience working with CMOs.
- Excellent communication skills both oral and written.
- Attention to detail, accuracy, and thoroughness expected in all aspects of work.
- Self-motivated with a strong sense of work ethic.
- This is the pay for this position
- Pay Transparency
Compensation
- $139,000 - $163,000 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.
- Participate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs).
Benefits
- Experience, Education and Specialized Knowledge and
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.
This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.