{"id":2284265,"url":"https://alion.io/job/pci-pharma-services-quality-operations-manager","title":"Quality Operations Manager","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":16,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-12T06:55:09Z"}},"role":"Management","role_family":"Management","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":156000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1015},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-17T00:00:00Z","employer_posted_date":"2026-08-17","last_verified_at":"2026-10-12T13:08:18Z","board_verified":true,"closed_at":null,"days_open":56,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":56},"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.\nSummary of Role\nThis operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.\nKey Responsibilities:\nQuality Leadership & Strategy\nLead the development and execution of quality operations, overseeing all batch manufacturing record generation, and review. Responsible for all production related quality assurance\nPartner with peer Quality Managers and Quality Systems Manager to drive QA optimization strategies and generate company-wide continuous improvement initiatives\nEstablish cross-functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability\nProcess Excellence & Compliance\nOwn the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality-related forms and records\nAuthorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction\nEnsure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner.\nTeam Leadership & Development\nProvide direction and leadership to the quality operations team (~10 direct reports), establishing performance frameworks and operational excellence standards\nImplement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators\nChampion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives\nOperationaxc\nExecute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations\nOversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution\nDirect quality operations across incoming goods receipt and related supply chain touchpoints\nCustomer & Stakeholder Management\nLead high-level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership\nServe as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening\nChampion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives. \nSubject Matter Expertise\nEstablish and maintain deep technical expertise in packaging and quality processes, serving as the go-to authority for customer and regulatory audit support\nDrive project leadership and cross-functional collaboration to meet evolving business requirements and organizational objectives\nEssential\nMinimum 10 years’ experience in Quality for a pharmaceutical company operating to EU GMP standards.\n2 -5 years’ experience in a leadership or team management role\nBroad and deep understanding of EudraLex Vol 4, its key chapters and annex's\nUnderstanding of serialisation requirements.\nA flexible and willing attitude\nCommunication skills to interact with internal and external customers at a senior level.\nStrong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, customers and suppliers\nDesign and develop new equipment to help improve line effectiveness.\nAbility to influence and collaborate at all levels in order to achieve company targets.\nAbility to represent the company in a professional and highly competent manner.\nAble to multitask and prioritise activities.\nAbility to work on their own as well as part of a team.\nExcellent problem-solving skills.\nDependable, reliable and robust personal integrity.\nDesirable\nExperience in a quality operations department, with responsibility for batch release in support of a Qualified Person Function\nExperience in hosting regulatory inspections\nDetailed understanding of both primary and secondary packaging processes.\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":5761,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-11T12:57:54Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.453,"p_room":0.36,"age_days":56,"expected_fill_days":36,"reasons":["conf:1","stale_co","win:tail","crowd:brand"],"computed_at":"2026-10-12T06:55:09Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-quality-operations-manager","json_url":"https://alion.io/job/pci-pharma-services-quality-operations-manager.json","meta":{"generated_at":"2026-10-12T15:22:19Z","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":"assistant_verified","counted_by":"address","units_charged":1,"used_today":3265,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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-pharma-services-quality-operations-manager"},{"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-pharma-services-quality-operations-manager"},{"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-pharma-services-quality-operations-manager"},{"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-pharma-services-quality-operations-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-quality-operations-manager"}]}