{"id":3999707,"url":"https://alion.io/job/pci-pharma-services-associate-director-qa-operations-visual-inspection","title":"Associate Director, QA Operations – Visual Inspection","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":"A","score":85,"open_postings":10,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":36,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-09T00:00:00Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-12T08:45:45Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"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.\nEssential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.\nBuild, coach, and scale a high-performing, site-wide QA-VI organization, establishing clear performance expectations, talent development pathways, and succession planning aligned with site and corporate strategic initiatives.\nManage departmental resources, operational workflows, and capital/operational planning to support continuous growth and site expansion.\nChampion the strategic growth and modernization of the Visual Inspection program. Lead the validation and implementation roadmap for advanced technologies, including automated visual inspection (AVI) equipment.\nContinually evaluate defect categories, classification systems, rates, and associated action/alert limits to ensure alignment with industry standards and pharmacopeial requirements.\nSpearhead campus-wide harmonization efforts related to QA-VI activities across the Bedford, NH facility, driving operational excellence, standardization, and process efficiency.\nPartner with cross-functional leadership to optimize final product inspection, AQL strategies, management of qualification kits, defect library maintenance, and final product retain inspection programs.\nProvide expert quality oversight and sign-off for complex Quality System events, including major investigations, critical deviations, and high-impact CAPAs.\nEnsure robust compliance with cGMP regulations, internal policies, and evolving global regulatory expectations. Maintain audit-readiness across all QA-VI functions.\nDevelop, monitor, evaluate, and present advanced Quality metrics and trends associated with QA-VI to site and corporate Senior Management.\nProactively identify, assess, and escalate product quality risks and observations, driving risk-mitigation strategies to protect product safety and supply continuity.\nServe as a primary SME and host for client audits and regulatory inspections (FDA, Health Authorities) concerning visual inspection, defect management, and product disposition.\nEnsure training programs are robust, dynamically updated, and that all staff maintain flawless qualification standing. Foster a culture of quality compliance, transparency, and data integrity.\nGuide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices\nSpecial Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.\nAbility to lead a site-based team\nAbility to manage other managers (direct reports)\nHonesty, integrity, respect and courtesy with all colleagues\nCreative with the ability to work with minimal supervision and balanced with independent thinking\nResilient through operational and organizational change\nAbility to coach, train, and mentor others\nCross functional staff, members of management, internal and external clients, members of the Quality organization\nAble to communicate effectively and tactfully\nAble to articulate and comprehend technical subject matter\nAble to comprehend, interpret, and articulate instructions set forth in local SOPs and regulatory guidance.\nWork Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nRequires the ability to lift, carry, push or pull light weights (up to 20 pounds)\nFrequent reading, writing, and verbal communication\nAble to translate ideas to actual concepts and processes\nProven ability to manage multiple projects (duties) simultaneously\nAble to work in a highly complex environment with competing demands and priorities\nAbility to observe, identify potential issues, and resolve satisfactorily.\nAbility to provide hands on leadership, coaching, and coordination of needed actions with a focus on achieving goals and deliverables. Must be able to manage, plan and multi-task with minimal guidance.\nSupport senior management as needed.\nFrequent travel between local Bedford, NH facilities.\nQualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nBachelor’s Degree in relevant scientific discipline. Minimum 10 years’ experience in GMP pharmaceutical or biotech industry, with 5+ years of experience in a Quality based role supporting clinical and/or commercial production, or equivalent combination of education and experience. \nPrior management experience in manufacturing, visual inspection, labeling/packaging, or Quality Assurance/Quality Control of sterile drug product is required.\nStrong understanding of regulatory visual inspection compendium and pharmacopeial standards, defect characterization.\nStrong technical writing skills to support investigations and risk assessments\nExceptional organizational skills and attention to detail\nAbility to make risk-based decisions and resolve issues with minimal guidance\nExcellent interpersonal skills and the ability to communicate well orally and in writing\nProficiency in MS Office including Word, and Excel\nExcellent verbal and written communication skills required\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":7270,"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":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-10T02:57:32Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"green card filings: 1","filings_12m":0,"filings_prev_12m":0,"green_card_filings_12m":1,"median_offered_wage_usd":72500,"route":null,"cap_exempt":false,"checked_at":"2026-11-12T07:36:15+00:00","sources":["US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":36,"reasons":["conf:1","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-12T10:38:37Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-associate-director-qa-operations-visual-inspection","json_url":"https://alion.io/job/pci-pharma-services-associate-director-qa-operations-visual-inspection.json","meta":{"generated_at":"2026-11-12T14:46:07Z","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":30739,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-associate-director-qa-operations-visual-inspection"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-associate-director-qa-operations-visual-inspection"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-associate-director-qa-operations-visual-inspection"},{"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-associate-director-qa-operations-visual-inspection\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-associate-director-qa-operations-visual-inspection"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3999707}},{"tool":"search_jobs","arguments":{"company":"pci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3999707},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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