{"id":3923052,"url":"https://alion.io/job/pci-pharma-services-senior-manager-msat","title":"Senior Manager, MSAT","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":86,"open_postings":11,"ghost_share":0,"stale_share":0.545,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Operations","role_family":"Operations","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":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":133920,"max":150660,"currency":"USD","period":"year","gross":null,"usd_annual":150660},"salary_estimate":null,"experience_years_min":7,"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":"2026-11-06T00:00:00Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-11T08:25:55Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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:\nThe Senior Manager, Technical Documentation provides strategic, technical, and operational leadership for the Manufacturing Science & Technology (MSAT) documentation function, ensuring the consistent application of cGMP requirements and documentation standards across technology transfers, new product introductions (NPI), process changes, and commercial manufacturing operations. The role establishes and governs site and segment-level documentation strategies, systems, and processes that support compliant, efficient, and scalable clinical and commercial manufacturing.\nThis position leads the development, oversight, and continuous improvement of Master Batch Records (MBRs), manufacturing procedures, technical reports, specifications, and associated controlled documentation. The Senior Manager serves as the technical authority for MSAT documentation, driving standardization, best practices, and governance across sites while ensuring documentation effectively supports technology transfer, process validation, manufacturing readiness, operational excellence, and regulatory compliance.\nThe role provides leadership for complex cross-functional initiatives, partnering closely with MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory, and Project Management teams to resolve technical issues, implement process improvements, and ensure successful execution of new and existing clinical and commercial programs. The position is responsible for establishing documentation governance, monitoring performance metrics and quality trends, assessing compliance risks, and driving continuous improvement initiatives that enhance product quality, inspection readiness, and operational efficiency.\nAs a key advisor to site and segment leadership, the Senior Manager develops long-term strategies, organizational capabilities, and documentation processes that align with business objectives, regulatory expectations, and growth plans. The position fosters a culture of technical excellence, compliance, and continuous improvement while enabling successful technology transfer, accelerated product introduction, and sustainable manufacturing performance across the network.\nEssential Duties and Responsibilities:\nEstablish and govern site and segment-wide MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.\nProvide strategic, technical, and operational leadership for the Technical Documentation function, ensuring consistent application of cGMP requirements and documentation best practices across the organization.\nLead the development, review, approval, implementation, and lifecycle management of Master Batch Records (MBRs), manufacturing procedures, specifications, technical reports, and other controlled GMP documentation.\nServe as the segment subject matter expert and technical authority for manufacturing documentation, providing guidance to MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, and Project Management teams.\nDirect documentation activities supporting technology transfers, process scale-up, process validation, new product introductions, and commercial manufacturing readiness\nEstablish governance processes and performance metrics to ensure documentation quality, compliance, execution efficiency, and inspection readiness across all sites.\nLead complex cross-functional initiatives to resolve technical, operational, and compliance challenges that impact manufacturing performance, product quality, and regulatory requirements.\nOversee documentation-related quality events, change controls, CAPAs, deviations, and technical investigations to ensure timely resolution, effectiveness verification, and continuous improvement.\nMonitor and trend documentation, process, and compliance metrics to identify systemic issues, assess organizational risk, and implement sustainable corrective and preventive actions.\nDrive standardization, harmonization, and continuous improvement of documentation systems, templates, workflows, and governance practices across the network.\nPartner with site and segment leadership to develop long-range strategies, organizational capabilities, and operating models that support business growth, technical excellence, and operational scalability.\nProvide leadership and oversight for departmental objectives, resource planning, project prioritization, and execution to ensure alignment with corporate goals and customer commitments.\nSupport internal audits, client audits, and regulatory inspections by ensuring documentation systems remain compliant, inspection-ready, and aligned with current regulatory expectations.\nMentor, develop, and lead Technical Documentation personnel while fostering a culture of accountability, continuous improvement, technical rigor, and operational excellence.\nRepresent the organization during client interactions, governance forums, technical reviews, and executive leadership discussions involving product transfers, manufacturing readiness, compliance strategy, and process improvement initiatives.\nDevelop and maintain strong collaborative relationships with internal stakeholders and external partners to ensure successful execution of technical and business objectives.\nEnsure compliance with all applicable PCI policies, cGMP regulations, quality standards, and Environmental Health and Safety (EHS) requirements.\nQualifications:\nBachelor’s degree in Life Sciences discipline or equivalent experience required.\nMinimum of seven (7) years of experience in aseptic manufacturing environments, microbiology or quality assurance.\nMinimum of three (3) plus years of leadership/supervisory experience.\nMust have an expert level of knowledge in global pharmaceutical cGMP’s.\nHas expert level understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation. \nMust be able to manage and lead in developing solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovativeness.\nDetail oriented and expert written and verbal communication skills.\nAbility to work autonomously, within prescribed guidelines, or as a team member.\nMust be able to manage and lead in developing employees and provide an environment that encourages development potential.\nMust be highly proficient at using Microsoft Office applications.\nDirects and provides expert knowledge of MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.\nSets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.\nMaintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.\nProvides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.\nThe base salary hiring range for this position is $133,920 - $150,660 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).\n#LI-AK2\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":9117,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity","Health insurance","Insurance coverage"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-07T16:50:39Z"}],"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":"2026-11-11T07:38:50+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":5,"expected_fill_days":38,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":150660,"is_top_pay":true},"html_url":"https://alion.io/job/pci-pharma-services-senior-manager-msat","json_url":"https://alion.io/job/pci-pharma-services-senior-manager-msat.json","meta":{"generated_at":"2026-11-11T12:20:30Z","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":21980,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"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-senior-manager-msat"},{"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-senior-manager-msat"},{"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-senior-manager-msat"},{"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-senior-manager-msat\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-senior-manager-msat"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3923052}},{"tool":"search_jobs","arguments":{"company":"pci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3923052},"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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