New · posted Oct 20
Summit Therapeutics · Biotechnology
Manager, Quality Assurance
- Princeton, NJ
- On-site
- Full-time
- Manager
Open until filled
The role
Overview of 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. The Manager will also be responsible for ensuring Summit departments and systems are inspection ready by way of conducting internal and external audits, supporting inspection readiness activities, and authoring and updating internal procedures and Quality Technical Agreements (QTA).
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.
What you need
Experience, Education and Specialized Knowledge and 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.
- Demonstrated ability working within an eQMS to manage and close quality records in accordance with established timelines.
- Experience working with CMOs.
- Excellent communication skills both oral and written.
- Ability to work in a fast paced environment and efficiently manage projects and timelines.
- Experience working individually and within a team while balancing priorities.
- 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
$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. 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.
What you'll do
Role and Responsibilities
- Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints.
- Ensure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations.
- Support product compliant reconciliation with the call center and Pharmacovigilance.
- Continuously improve the internal product complaint program in accordance with applicable laws and regulations.
- Serve as Auditor for internal audits and external audits.
- Ensure internal and external audit responses and appropriate CAPAs are identified and managed through to resolution in a timely manner and deliverables are met.
- Continuously improve internal and external audit programs to remain current with applicable laws and regulations.
- Provide support for the initial review, periodic review, and revision of Summit QTAs.
- Write, revise, review and/or approve SOPs and other controlled documents.
- Ensure issues are identified and managed through resolution in a timely manner, management is notified, and deliverables are met.
- Participate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs).
- Support GMP inspection readiness activities.
- All other duties as assigned.
Pay and benefits
$139,000 – $163,000 a year
Employer providedBonus
Stock
Benefits package
Where you'll work
Princeton, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Princeton, NJFrom the posting
About Summit Therapeutics
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. 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:
Equal opportunity, accessibility and legal noticesSummit Therapeutics's statements, word for word
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 Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
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.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in New Jersey8 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $139,000 | — | $163,000 |
| New Jersey (middle half) | $134,750 | $143,750 | $172,875 |
| All US (middle half) | $131,500 | $155,000 | $168,000 |
This role: Summit Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Summit Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Investigations and CAPA6
- Documentation and SOPs3
- Collaboration and leadership2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme
Company hiring pulse
Summit Therapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 3
- Locations
By discipline
- Regulatory4 67%
- Quality2 33%
By level
- Director4 67%
- Manager2 33%
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Manager, Quality Assurance at Summit Therapeutics
Open until filled. $139K–$163K a year, employer provided.