Manager, Quality Assurance

Summit Therapeutics; Princeton (NJ); On-site; USD 139,000 - 163,000; Full time

Job summary

Summit Therapeutics is seeking a Manager of QA to oversee the product complaint program for both clinical and commercial materials. You will drive investigations, ensure regulatory alignment, and lead internal and external audits while maintaining inspection readiness.

You will manage QTAs, author SOPs, and collaborate with CMOs and Pharmacovigilance. A strong background in GMP/GDP and eQMS is essential in a fast-paced biopharma setting in the United States.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biotechnology, or 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 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 quality records.
• 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.

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 complaint 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 CAPAs are identified and managed to resolution.
• Continuously improve internal and external audit programs to stay current with laws and regulations.
• Provide support for the 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 with timely notification and deliverables.
• Participate in developing, reporting, reviewing and trending of quality and performance metrics (APR support).
• Support GMP inspection readiness activities.
• All other duties as assigned.

Skills

Quality Assurance

Product Complaints

Auditing

GMP/GDP Knowledge

eQMS

CMOs

Regulatory Knowledge

Communication

Project Management

Education

Bachelor’s degree in life sciences

Tools

eQMS software

Job description

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.

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.

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).

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.

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.

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.

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 [e-mail] 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Summit Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.