{"id":1929476,"url":"https://alion.io/job/pci-senior-manager-client-quality-technical-and-validation","title":"Senior Manager, Client Quality, Technical and Validation","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":17,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-13T05:45:00Z"}},"role":"Marketing","role_family":"Marketing","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tredegar, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":55000,"max_usd":110000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":81},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-13T03:27:28Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur 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.\nAccountable for Overall Area Performances\nProvide strategic leadership across the Client Quality Account Management and Validation functions.\nLead and develop the Quality Account Manager team, ensuring effective oversight of client quality requirements, NPI, licensing, regulatory submissions, Quality Agreements and ongoing quality activities.\nLead and develop the qualification and validation activities for process, equipment, utilities, cleaning and computer systems.\nAct as a senior escalation point for complex client, technical, regulatory and quality matters.\nEnsure quality activities are scientifically robust, compliant with applicable GMP requirements and aligned with product quality and business objectives.\nProactively identify and manage risks that could affect customer delivery, product quality, timelines or business performance.\nProvide daily leadership and oversight of all areas and develop metrics to monitor and support the business.\nMaintain effective client relationships and ensure quality documentation and information are available to support timely product release.\nEnsure validation programmes are risk-based, scientifically sound, and compliant and delivered to agreed customer and business timelines.\nReview and approve client documentation and validation protocols, reports, summary reports and associated change control documentation.\nSupport the hosting and management of client and regulatory audits and inspections.\nDevelop, review and implement systems and processes that improve quality performance, communication and information management.\nDirect and manage efficient utilisation of staff resources in order to meet project goals and timelines\nTo liaise with Business Development in the preparation of proposals requiring QP input.\nTo 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\nApprove Changes as per change control SOP and take an active role in the Change Control Committee when required.\nTo 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\nConduct GxP training to other area personnel and contribute to GxP packages where necessary\nThe job holder is responsible for adhering to PCI SOP’s, Health & Safety, GMP and other regulatory guidelines themselves and by team members. \nPeople Management\nLead, develop and motivate the Quality Account Management and Validation teams.\nEstablish clear objectives, priorities and performance expectations aligned with customer, quality and business requirements.\nEnsure appropriate training, competency development and succession planning within the functions.\nManage departmental resources, budgets and workload to ensure effective delivery of customer and business priorities.\nMonitor performance against agreed KPIs, including quality, compliance, customer delivery, project timelines and resource utilisation.\nPromote a culture of accountability, collaboration, technical excellence and customer focus.\nContinuous Improvement\nDrive continuous improvement across Client Quality and Validation processes to improve quality, efficiency and customer experience.\nIdentify opportunities to simplify, standardise and strengthen quality processes while maintaining regulatory compliance.\nRegulatory Compliance\nEnsure that a high level of regulatory compliance is achieved and maintained across site by:\nPerforming gap analysis on each revised regulatory requirements and identify areas where changes are required to insure and maintain compliance\nInitiate and coordinate technical projects that are required to maintain /improve the set level of regulatory compliance\nProject leadership for equipment/process related projects from initiation through to handover\nAssist development of PCI Project Documentation Systems\nGeneral/Other duties\nEnsure compliance with GMP, company SOPs, Health & Safety and Environmental requirements.\nMaintain appropriate continuing professional development and remain current with relevant regulatory and industry developments.\nProvide expert Quality, Technical and Validation advice to customers and internal stakeholders.\nUndertake internal, cross-functional and ad hoc projects as required to meet business and customer needs.\nUndertake other duties as assigned by the Snr Director of Quality within the scope of the role.\nWork Experience, Skills Required & Specific Knowledge\nEssential\nOver extensive experience working in a Quality function for a Pharmaceutical Company\nExcellent communication skills both verbal and written are required in this role and people management skills\nAbility to show success in managing employees. \nStatistical and Advanced Mathematical Skills\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. \nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nHighest 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.\nAbility to Travel\nHigh Standard of Report Writing\nSupporting Regulatory Inspections by international regulatory bodies\nAbility to effectively present information to various people as the job requires.\nAbility to identify and resolve problems in a timely manner.\nAbility to display original thinking and creativity.\nAbility to demonstrate attention to detail. \nAbility to set and achieve challenging goals. \nBehavioural Skills - Site\nThe role requires a professional and collaborative approach to work, demonstrating integrity, accountability, and respect for others.\nThe postholder is expected to communicate effectively, work positively with colleagues and stakeholders, adapt to change, and manage priorities to deliver high-quality outcomes.\nA commitment to continuous learning, inclusion, and maintaining a safe and respectful working environment is essential.\nQualifications:\nBachelor's Degree in a related field and/or 10+ years related experience and/or training.\nAspire to or is eligible to act as a Qualified Person under 75/319/EC (2001/83/EC)\nA Continuous Improvement Qualification - Green Belt in Lean or Six Sigma\nManagement Qualification ILM Level 5 or above\nRegulatory/Industry Responsibilities:\nGeneral\nThe job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines\nAttendance to work is an essential function of this position\nThis position may require overtime and/or weekend work.\nThe job holder should ensure they read all other training documentation promptly and no more than 10 documents in a working day\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt 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.","description_format":"text","description_chars":8431,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Clinical Trial Services (CRO)","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-05T21:20:39Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.561,"p_room":0.9,"age_days":19,"expected_fill_days":28,"reasons":["conf:2","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/pci-senior-manager-client-quality-technical-and-validation","json_url":"https://alion.io/job/pci-senior-manager-client-quality-technical-and-validation.json","meta":{"generated_at":"2026-10-13T16:25:04Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":24959,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1987116},"rest":"https://alion.io/mcp/rest/get_company?id=1987116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpci-senior-manager-client-quality-technical-and-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fpci-senior-manager-client-quality-technical-and-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fpci-senior-manager-client-quality-technical-and-validation"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/pci-senior-manager-client-quality-technical-and-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-senior-manager-client-quality-technical-and-validation"}]}