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 a Pharmaceutical Company
• Excellent communication skills both verbal and written are required in this role and people management skills
• Ability to show success in managing employees.
• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• Ability to Travel
• High Standard of Report Writing
• Supporting Regulatory Inspections by international regulatory bodies
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to demonstrate attention to detail.
• Ability to set and achieve challenging goals.

Behavioural Skills - Site

• The role requires a professional and collaborative approach to work, demonstrating integrity, accountability, and respect for others.
• The postholder is expected to communicate effectively, work positively with colleagues and stakeholders, adapt to change, and manage priorities to deliver high-quality outcomes.
• A commitment to continuous learning, inclusion, and maintaining a safe and respectful working environment is essential.

Qualifications:

• Bachelor's Degree in a related field and/or 10+ years related experience and/or training.
• Aspire to or is eligible to act as a Qualified Person under 75/319/EC (2001/83/EC)
• A Continuous Improvement Qualification - Green Belt in Lean or Six Sigma
• Management Qualification ILM Level 5 or above

Regulatory/Industry Responsibilities:

General

• The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines
• Attendance to work is an essential function of this position
• This position may require overtime and/or weekend work.
• The job holder should ensure they read all other training documentation promptly and no more than 10 documents in a working day

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.