{"id":1789003,"url":"https://alion.io/job/west-pharmaceutical-services-quality-compliance-manager","title":"Quality Compliance Manager","company":{"id":1923607,"name":"West Pharmaceutical Services","domain":"westpharma.com","url":"https://alion.io/company/westpharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Greenfield, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":86000,"max_usd":161000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4830},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-16T00:00:00Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-28T01:21:45Z","board_verified":true,"closed_at":null,"days_open":42,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":42},"description":"This is an onsite position requiring the team member to be onsite 5 days a week.No relocation is provided for this opportunity.\nAt West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?\nThere’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.\nWe believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.\n Job Summary\nThe Quality Compliance Manager leads the governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains effective, inspection-ready and compliant with applicable drug product, medical device, combination product, customer and West requirements. The position leads the Quality Systems team and is responsible for Quality Systems, regulatory readiness, supplier quality governance, risk management and continuous improvement. The Quality Systems Manager reports into the Site Quality Director.\nEssential Duties and Responsibilities\nLead, develop and coach the Quality Systems team through effective performance management, succession planning and capability development.\nOwn the site QMS, ensuring effective governance, compliance, process ownership, performance monitoring and continual improvement.\nOversee deviations and non-conformances, CAPA, change control, complaints, document control, training, Management Review, Product Quality Review, supplier quality, validation governance and quality risk management.\nDevelop and implement the site Quality Systems strategy and roadmap, aligned with regulatory, customer and West requirements.\nLead sustained audit and inspection readiness and act as the primary Quality Systems representative during customer, corporate, regulatory and Notified Body audits and inspections.\nProvide regulatory compliance leadership, monitor emerging requirements and ensure implementation of required changes, submissions, regulatory commitments and manufacturing authorization requirements.\nAct as the primary liaison with customers, regulatory authorities, the Qualified Person, Corporate Quality and other West sites on Quality Systems and compliance matters.\nProvide Quality Systems oversight of new product introductions, technology transfers, validation programs and operational changes, including the review and approval of Validation Master Plans, validation protocols, reports and associated validation documents, in accordance with the approved site authorization matrix.\nEstablish, monitor and report QMS performance through KPIs, trend analysis and Management Review, ensuring timely escalation and resolution of quality risks and adverse trends.\nDrive standardization, risk-based decision-making and continuous improvement through simplification, harmonization, data analysis and adoption of best practices.\nChampion a patient-first and right-first-time quality culture and represent Dublin in enterprise Quality System initiatives and global program deployment.\nEnsure compliance with company policies, Quality and EHS requirements, the Guiding Principles and the Corporate Code of Conduct.\nPerform other duties as assigned\nEducation\nBachelor’s Degree in a technical discipline to include; Science, Quality or Engineering or equivalent experience \nWork Experience\nMinimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.\nProven experience in Medical Device and Pharmaceutical Packaging and Combination Products regulations e.g., EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21CFR Part 820 QMSR.\nExperience developing and maintaining a QMS supporting EU and US markets and hosting customer, corporate and regulatory audits or inspections.\nProven general leadership and quality management experience which includes quality execution, analysis and deadline driven.\nExcellent computer skills, experience with MS Office, ERP systems, Statistical software etc. \nDemonstrated experience leading people, Quality Systems, compliance programs or cross-functional quality improvement initiative.\nPreferred Knowledge, Skills and Abilities\nWorking knowledge of applicable EU GMP requirements, ISO 13485, ISO 14971 and US 21 CFR Parts 210, 211, 820 QMSR and Part 4.\nLead auditor qualification or equivalent audit experience; supplier audit experience is desirable.\nStrong leadership, coaching, stakeholder management, analytical, organizational and communication skills.\nAbility to prepare clear, concise and audit-ready documentation, analyze trends and drive sustainable corrective and preventive action.\nLean Sigma training, ideally Green Belt level, with experience leading improvement programs.\nAdditional Requirements\nThrive in a fast-paced environment where teamwork and collaboration drive success.\nBring a positive, can-do attitude every day as we build and grow together.\nContribute to ramping up a state-of-the-art manufacturing facility from the ground up.\nEmbrace change and innovation as we launch new operations at record speed.\nWork hard, stay flexible, and support your teammates to achieve shared goals.\nTake pride in producing high-quality products that improve patient lives worldwide.\nLive West’s core values of integrity, teamwork, and accountability in everything you do.\nBe part of a culture that celebrates learning, problem-solving, and continuous improvement.\nShow initiative and ownership while helping shape a safe, efficient, and high-performing workplace.\nGrow your career and skillset in a dynamic, innovative environment where your contributions truly matter. #LI-JJ1 #LI-ONSITE\nTravel Requirements\n10%: Up to 26 business days per year\nPhysical Requirements\nSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.\nWest is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.","description_format":"text","description_chars":7305,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Health Care","Manufacturing","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-03T17:38:23Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 16 · green card filings: 7","filings_12m":16,"filings_prev_12m":17,"green_card_filings_12m":7,"median_offered_wage_usd":104457,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.752,"p_room":0.36,"age_days":42,"expected_fill_days":26,"reasons":["conf:4","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/west-pharmaceutical-services-quality-compliance-manager","json_url":"https://alion.io/job/west-pharmaceutical-services-quality-compliance-manager.json","meta":{"generated_at":"2026-10-28T06:38:02Z","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":8910,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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":1923607},"rest":"https://alion.io/mcp/rest/get_company?id=1923607"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwest-pharmaceutical-services-quality-compliance-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%2Fwest-pharmaceutical-services-quality-compliance-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%2Fwest-pharmaceutical-services-quality-compliance-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/west-pharmaceutical-services-quality-compliance-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwest-pharmaceutical-services-quality-compliance-manager"}]}