Senior Manager, Client Quality, Technical and Validation

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Accountable for Overall Area Performances

Provide strategic leadership across the Client Quality Account Management and Validation functions.

Lead and develop the Quality Account Manager team, ensuring effective oversight of client quality requirements, NPI, licensing, regulatory submissions, Quality Agreements and ongoing quality activities.

Lead and develop the qualification and validation activities for process, equipment, utilities, cleaning and computer systems.

Act as a senior escalation point for complex client, technical, regulatory and quality matters.

Ensure quality activities are scientifically robust, compliant with applicable GMP requirements and aligned with product quality and business objectives.

Proactively identify and manage risks that could affect customer delivery, product quality, timelines or business performance.

Provide daily leadership and oversight of all areas and develop metrics to monitor and support the business.

Maintain effective client relationships and ensure quality documentation and information are available to support timely product release.

Ensure validation programmes are risk‑based, scientifically sound, and compliant and delivered to agreed customer and business timelines.

Review and approve client documentation and validation protocols, reports, summary reports and associated change control documentation.

Support the hosting and management of client and regulatory audits and inspections.

Develop, review and implement systems and processes that improve quality performance, communication and information management.

Direct and manage efficient utilisation of staff resources in order to meet project goals and timelines

To liaise with Business Development in the preparation of proposals requiring QP input.

To ensure GMP compliance across the PCI Tredegar Organisation by: making regular visits to operational departments and offering advice and guidance with respect to regulatory expectations and recognised best practice

Approve Changes as per change control SOP and take an active role in the Change Control Committee when required.

To review deviations and change controls and use technical/professional judgement to make appropriate product quality decisions (in association with site QP's) and initiate and promote quality improvements

Conduct GxP training to other area personnel and contribute to GxP packages where necessary

The job holder is responsible for adhering to PCI SOP's, Health & Safety, GMP and other regulatory guidelines themselves and by team members.

People Management

Lead, develop and motivate the Quality Account Management and Validation teams.

Establish clear objectives, priorities and performance expectations aligned with customer, quality and business requirements.

Ensure appropriate training, competency development and succession planning within the functions.

Manage departmental resources, budgets and workload to ensure effective delivery of customer and business priorities.

Monitor performance against agreed KPIs, including quality, compliance, customer delivery, project timelines and resource utilisation.

Promote a culture of accountability, collaboration, technical excellence and customer focus.

Continuous Improvement

Drive continuous improvement across Client Quality and Validation processes to improve quality, efficiency and customer experience.

Identify opportunities to simplify, standardise and strengthen quality processes while maintaining regulatory compliance.

Regulatory Compliance

Ensure that a high level of regulatory compliance is achieved and maintained across site by:

Performing gap analysis on each revised regulatory requirements and identify areas where changes are required to insure and maintain compliance

Initiate and coordinate technical projects that are required to maintain /improve the set level of regulatory compliance

Project leadership for equipment/process related projects from initiation through to handover

Assist development of PCI Project Documentation Systems

General/Other duties

Ensure compliance with GMP, company SOPs, Health & Safety and Environmental requirements.

Maintain appropriate continuing professional development and remain current with relevant regulatory and industry developments.

Provide expert Quality, Technical and Validation advice to customers and internal stakeholders.

Undertake internal, cross-functional and ad hoc projects as required to meet business and customer needs.

Undertake other duties as assigned by the Snr Director of Quality within the scope of the role.

Work Experience, Skills Required & Specific Knowledge

Essential Over extensive experience working in a Quality function for