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