Quality Assurance Manager

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to easing the burden of serious diseases, improving quality of life, and extending life where possible. The company is driven by a team of skilled professionals who share a strong commitment to integrity, excellence, urgency, collaboration, and care for people. Summit values its employees as the foundation of its culture and progress.

The organization is focused on clinical research in oncology and is advancing several global Phase 3 studies across non-small cell lung cancer and colorectal cancer. Its investigational therapy, ivonescimab, is not approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and also operates in California, New Jersey, the UK, and Ireland.

Role Summary

The Quality Assurance Manager will oversee quality assurance operations to support compliance with EU GMP, applicable regulatory expectations, and internal standards. The position includes responsibility for quality systems, batch release oversight, audits, and ongoing improvement programs. This role will serve as a central point of coordination between manufacturing, regulatory, supply chain, and quality teams to protect product quality and patient safety while supporting development and commercialization activities.

Key Responsibilities

• Manage remote batch release activities and provide live quality oversight for manufacturing and testing carried out by global CMOs and contract testing laboratories.
• Review, approve, and track batch documentation through digital quality systems and electronic batch record platforms.
• Work closely with CMOs, CDMOs, and supply chain partners to support the Qualified Person in batch certification and release.
• Ensure batch records and related documents are reviewed and approved within required timelines.
• Act as subject matter expert for Responsible Person activities, ensuring products are transported, stored, and delivered in line with the license and GDP requirements, while safeguarding against tampering, theft, or counterfeiting.
• Maintain and strengthen the Pharmaceutical Quality System in line with EU GMP and ICH expectations.
• Oversee CAPA, deviations, change control, and quality risk assessments within the EU quality framework.
• Ensure ongoing compliance with EU GMP, ICH, HPRA, and EMA requirements.
• Lead QA and QMS initiatives and keep SOPs and quality documents current and compliant.
• Provide GMP training and guidance to junior QA colleagues.
• Carry out audits of CMOs, CDMOs, and suppliers to confirm GMP compliance.
• Prepare for and host regulatory inspections as well as internal and external audits, then drive corrective actions and continuous improvement plans.

Requirements

• BSc, MSc, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or a closely related field.
• At least 5 years of experience in a GMP-regulated pharmaceutical or biotechnology setting.
• Hands-on exposure to remote batch release, electronic batch records, and digital QMS tools.
• Strong understanding of GDP and prior Responsible Person experience.
• Solid working knowledge of EU regulatory expectations, HPRA and EMA requirements, and GMP compliance across global supply chains.
• Background in conducting audits and managing regulatory inspections.
• Experience working with CMOs/CDMOs and overseeing outsourced manufacturing.
• Demonstrated ability to influence and lead within a global cross-functional environment.
• Strong analytical and problem-solving capability for handling complex quality issues remotely.
• Excellent communication and leadership skills.

Preferred Experience

• Exposure to sterile manufacturing or biologics is an advantage.
• Eligibility for, or interest in becoming, a Qualified Person is desirable.
• Experience in a virtual biopharma environment would be beneficial.
• Prior CMO oversight experience would be an added plus.

What We Offer

• A competitive salary and benefits package.
• The chance to work in a fast-moving and innovative setting.
• Support for professional growth, development, and training.

Additional Information

Compensation is determined individually and may vary depending on skills, depth of experience, certifications, and work location. The overall package may also include bonus pay, stock, benefits, and other variable compensation elements.

Equal Opportunity

Summit Therapeutics is committed to maintaining an inclusive workplace and does not discriminate on the basis of race, color, religion, gender, national origin, age, sexual orientation, marital status, veteran status, disability, or any other legally protected characteristic.

Agency Notice

The company does not accept candidate referrals from employment agencies or employment businesses for these vacancies unless prior written authorization has been obtained from Summit’s Talent Acquisition team.