Senior Specialist, QA

The role

The Senior Specialist, QA provides operational leadership and quality oversight for the review, approval and release-readiness of clinical and commercial product batches. This person coordinates batch-release activities across multiple departments and external partners to ensure compliance with GMP requirements.

What you will do

• Coordinate end-to-end QA review of executed batch manufacturing, packaging, testing and release documentation.
• Coordinate preparation and collation of batch documentation for final batch disposition or QP certification.
• Verify batch records are complete, accurate, and compliant with approved procedures and GMP requirements.
• Confirm relevant deviations, investigations, change controls, CAPAs, and laboratory results are approved before release.
• Identify documentation gaps and coordinate timely resolution.
• Maintain oversight of batch-release priorities, review status, and planned release dates.
• Ensure batch-release documentation is appropriately archived electronically.
• Review and approve relevant quality documents including SOPs, work instructions, forms, and checklists.
• Provide leadership and technical guidance to QA batch reviewers.
• Support regulatory inspections, customer audits, internal audits, and supplier audits.

Required qualifications

• Recognized qualification in Quality, Pharmaceutical Science, Life Sciences, Engineering or related discipline.
• Significant experience in Quality Assurance within a pharmaceutical, biopharmaceutical or similarly regulated manufacturing environment.
• Practical experience reviewing executed batch records and supporting batch disposition or QP certification activities.
• Knowledge of GMP, Good Documentation Practice, and data-integrity requirements.
• Experience working with deviations, investigations, CAPAs, and change controls.
• Experience using electronic quality, document management and other enterprise-systems such as MasterControl, NetSuite, Veeva Vault, TrackWise, SAP or equivalent platforms.
• Demonstrated ability to coordinate multiple priorities and deliver against critical release timelines.
• Experience supporting the release of medicinal products or investigational medicinal products.
• Experience working with contract manufacturing organizations and external testing laboratories

Nice to have

• Experience in Biologic manufacturing, Packaging and Labelling environments

Benefits

• Bonus
• Stock
• Benefits
• Other applicable variable compensation

About the company

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.