{"id":3364356,"url":"https://alion.io/job/pci-pharma-services-manager-qa-doc-control","title":"Manager, QA - Doc Control","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":82,"open_postings":19,"ghost_share":0,"stale_share":0.737,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-10-30T05:48:23Z"}},"role":"QA","role_family":"QA","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":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":140000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":648},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-27T22:28:50Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-30T00:41:43Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"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 Objective:\nThe QA Manager - Document Control will lead the QA Document Control team across multiple production facilities in a regulated GMP environment. This position ensures the effective management and lifecycle maintenance of controlled documents, procedures, and records while fostering compliance with internal policies and external regulatory requirements. The role also includes driving strategic improvements to document control systems, mentoring staff, and promoting a collaborative work culture.\nEssential Duties and Responsibilities:\nProvide direction and oversight to QA Document Control team across multiple facilities, ensuring operational excellence.\nMentor and manage team members, fostering professional development and a collaborative, high-performing culture.\nPromote clear, concise, and timely communication to senior management and cross-functional teams.\nOversee the issuance, revision, and archiving of GMP-controlled documents, including Batch Records, Testing Data Sheets, Equipment Log Books, and Quality System documents.\nServe as the business process owner and administrator for the eQMS document module, ensuring continuous improvement and system optimization.\nFacilitate client approvals for Batch Records and manage periodic SOP reviews in collaboration with stakeholders.\nConduct internal audits of the eQMS document module to ensure compliance with regulatory and organizational requirements.\nSupport client audits and regulatory inspections by ensuring documentation readiness.\nCollaborate with cross-functional teams to address document control, aligning with broader business objectives.\nIdentify and implement process improvements to enhance efficiency, compliance, and effectiveness within QA operations.\nDevelop and maintain site-level metrics to monitor the performance of QA Document Control activities.\nAnalyze data to identify trends, gaps, and opportunities for improvement, sharing actionable insights with leadership.\nTrack and report compliance metrics, such as training completion rates, document approval timelines, and audit findings, to ensure consistent operational standards.\nWrite and revise QA SOPs related to document control processes.\nParticipate in investigations related to document control activities and recommend corrective actions.\nPerform other duties as assigned by senior management.\nSpecial Demands:\nAbility to communicate effectively through speech, vision, hearing, and written word.\nCapable of managing multiple projects simultaneously in a complex environment.\nMust be able to sit or stand for prolonged periods and occasionally lift up to 20 pounds.\nRequires occasional travel (~10%).\nWork Environment:\nEnclosed Document Control Filing Rooms: Frequent work in secure and enclosed filing rooms to manage, organize, and archive controlled documents in compliance with GMP requirements.\nOffice Setting: Standard office environment with desk work, computer use, and meetings.\nProduction Facility Areas: Occasional presence in cleanroom or production facility areas to collaborate with staff and support QA-related activities.\nQualifications:\nBachelor's degree in a related field with 5-8 years of relevant experience in an FDA-regulated environment.\n5+ years Document Control experience\nPrevious experience with an electronic Quality Management System, MasterControl preferred\nAlternatively, a High School Diploma/Associate’s Degree with 10+ years of GMP experience.\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. 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