Senior Specialist, QA

Overview of Role: 

The Senior Specialist, QA will provide operational leadership and quality oversight for the review, approval and release-readiness of clinical and commercial product batches. 

The role is responsible for ensuring that batch documentation is complete, accurate, traceable, and compliant with applicable GMP requirements, approved procedures and regulatory commitments before submission to QA for final disposition or QP certification. The person will coordinate batch-release activities across Quality, Manufacturing, Supply Chain, Regulatory Affairs and external manufacturing partners, ensuring that issues are identified, escalated and resolved in a timely manner. The position will also lead process improvements, support inspection readiness and promote high standards of data integrity and Good Documentation Practice across the batch-release process. 

Key Responsibilities 

• Batch Review and Release Readiness 

• Coordinate the end-to-end QA review of executed batch manufacturing, packaging, testing and release documentation for IMP and Commercial biological batch records. 

• Coordinate the preparation and collation of batch documentation required for final batch disposition or QP certification from internal and external sources. 

• Verify that batch records are complete, accurate, and compliant with approved procedures, specifications and applicable GMP requirements. 

• Confirm that relevant deviations, investigations, change controls, CAPAs, and laboratory results have been appropriately assessed and approved before release. 

• Identify documentation gaps, discrepancies and potential compliance risks, and coordinate their timely resolution. 

• Maintain oversight of batch-release priorities, review status, outstanding actions, and planned release dates. 

• Escalate critical issues or potential delays to Quality leadership and relevant stakeholders. 

• Ensure that batch-release documentation is appropriately archived and readily retrievable electronically. 

• Quality Systems and Compliance: 

• Ensure batch-release activities are performed in accordance with current GMP, Good Documentation Practice, data-integrity principles, and internal procedures. 

• Support the effective operation of quality systems associated with deviations, CAPAs, change controls, document control, and training. 

• Review and approve relevant quality documents, including SOPs, work instructions, forms, checklists, and batch-release procedures. 

• Maintain controlled documentation and ensure that current approved versions are available to relevant personnel. 

• Support periodic reviews of procedures and identify opportunities to strengthen compliance and operational effectiveness. 

• Promote the appropriate use of electronic quality and document management systems. 

• Act as a subject-matter expert for batch documentation, release-readiness and associated document-control processes for all batch release activities. 

• Internal Team Coordination (EU QA) 

• Provide day-to-day leadership and technical guidance to QA batch reviewers and supporting personnel. 

• Plan and allocate batch-review activities according to business priorities, product demand, and release timelines. 

• Monitor team workload, quality metrics, and completion of assigned activities. 

• Develop and deliver training in Good Documentation Practice, batch-record review and relevant quality-system processes. 

• Support onboarding and qualifications of new QA team members. 

• Foster a collaborative, accountable, and continuous-improvement culture within the QA function. 

• External Team Collaboration: 

• Work closely with Manufacturing, Quality Control / CMC, Supply Chain, Regulatory Affairs, Clinical Supply and other relevant functions to support timely batch release. 

• Coordinate with all Summit CMOs, testing laboratories and service providers to obtain missing documents and resolve release-related queries. 

• Communicate batch status, risks, priorities and outstanding actions clearly to internal and external stakeholders. 

• Support changes affecting batch documentation or release processes. 

• Participate in cross-functional meetings concerning batch disposition, documentation, readiness, and supply continuity internally. 

• Inspection Readiness and Continuous Improvement 

• Maintain batch-release processes and supporting records in a continuous state of inspection of readiness. 

• Support regulatory inspections, customer audits, internal audits, and supplier audits. 

• Retrieve and present batch documentation and quality-system records during audits and inspections. 

• Track batch-review metrics, recurring documentation issues, cycle times, and overdue actions. 

• Analyse trends and recommend improvements to increase efficiency, right-first-time performance and compliance. 

• Lead or contribute to Lean and process-optimization initiatives within the batch-release function. 

• Support the implementation and enhancement of electronic quality, document management and reporting systems. 

Qualifications and Experience 

• Essential 

• 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 – preferably in Biologic manufacturing, Packaging and Labelling environments.  

• 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 - 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 

• Key Competencies 

• Strong attention to detail and documentation accuracy 

• Sound quality and compliance judgement 

• Leadership and team coordination 

• Effective prioritization and workload management 

• Problem-solving and risk-based decision-making 

• Clear communication and stakeholder management 

• Audit and inspection readiness 

• Data integrity and information governance 

• Process improvement and operational efficiency 

• Ability to work independently in a fast-paced environment