{"id":3783897,"url":"https://alion.io/job/pci-pharma-services-supervisor-quality-systems","title":"Supervisor, Quality Systems","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":38,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-04T00:00:00Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-08T09:36:39Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"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 Supervisor, Quality Systems supports the execution and maintenance of the Quality Management System across the San Diego D&M sites in support of GMP manufacturing operations. This role helps ensure site quality systems are effectively implemented, compliant, inspection-ready, and aligned with applicable U.S. and international regulatory requirements.\nThe Supervisor provides day-to-day oversight of assigned Quality Systems activities, personnel, and workflows. Responsibilities include coordinating the review, approval, and timely completion of quality records; supporting the implementation and continuous improvement of QMS processes; and ensuring departmental priorities are executed in accordance with site procedures and regulatory expectations.\nThis position also supports site Quality KPI reporting by monitoring data accuracy, identifying trends and risks, and escalating performance concerns to Quality leadership.\nShift: 1st\n8AM-5P M\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.\nSupervise the daily execution of assigned Quality Systems processes and activities.\nEnsure quality records are complete, accurate, timely, and maintained in an inspection-ready state.\nCoordinate the review, approval, tracking, and closure of QMS records, which may include deviations, investigations, CAPAs, change controls, quality events, document control, and training activities.\nAssign work, establish priorities, monitor progress, and escalate risks or barriers that may affect compliance or business timelines.\nProvide coaching, technical guidance, and performance feedback to Quality Systems team members.\nSupport the implementation, maintenance, and continuous improvement of site QMS procedures and programs.\nPartner with Manufacturing, Quality Control, Validation, Engineering, and other site functions to resolve quality-system issues and support GMP operations.\nSupport Quality KPI data collection, verification, reporting, and trend analysis.\nIdentify overdue records, recurring issues, and adverse trends, and assist with the development of appropriate recovery or improvement plans.\nSupport client requests, audits, regulatory inspections, and inspection-readiness activities.\nServe as a Quality Systems subject-matter resource for assigned processes.\nPromote accountability, compliance, collaboration, and continuous improvement within the team.\nPerform additional duties as required to support site Quality and business objectives.\nLeadership Expectations\nProvide clear direction and maintain accountability for daily execution.\nCommunicate priorities, risks, and performance concerns promptly.\nApply sound judgment when assessing quality and compliance issues.\nDevelop team capability through coaching, cross-training, and effective delegation.\nFoster strong cross-functional partnerships and a proactive quality culture.\nEnsure timely escalation and resolution of issues affecting compliance, customers, or site objectives.\nDrive timely decision-making, escalation, and resolution of significant quality concerns.\nEstablish sustainable processes rather than short-term corrective actions.\nBuild strong cross-functional and client relationships.\nPromote a proactive, inspection-ready Quality culture.\nCoach and develop team members while maintaining high standards for execution and compliance.\nRegular and reliable on-site attendance on a full-time basis.\nResponsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.\nEmbodies PCI Pharma Services’ cultural values and aligns daily actions with department goals and company culture.\nQualifications: The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.\nHigh School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred; equivalent combination of education and/or relevant work experience will be considered.\n5-7+ years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry.\nPrevious experience as a supervisor, team lead, project lead, or senior individual contributor with responsibility for coordinating work and supporting employee development preferred.\nDemonstrated knowledge of GMP regulations and quality-system requirements, including applicable FDA, EU, and international regulatory expectations.\nExperience managing or supporting deviations, investigations, CAPAs, change controls, document control, training, audits, inspections, and quality metrics.\nExperience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations preferred.\nDemonstrated experience interacting with clients, regulatory agencies, and internal or external auditors.\nStrong analytical, organizational, problem-solving, and decision-making skills.\nAbility to manage multiple priorities in a fast-paced, complex manufacturing environment.\nStrong written, verbal, presentation, and stakeholder-management skills.\nProficiency with electronic quality management systems and quality-data reporting tools preferred.\nSuccess Measures\nTimely, accurate, and compliant execution of assigned Quality Systems activities.\nConsistent delivery of complete, inspection-ready records with reduced rework and improved right-first-time performance.\nEffective prioritization of team workload to meet site, client, and regulatory commitments.\nImproved performance against key QMS metrics, including record aging, overdue actions, closure timelines, and review-cycle efficiency.\nEarly identification and escalation of compliance risks, resource constraints, and operational barriers.\nClear accountability across the team through effective delegation, follow-up, coaching, and performance management.\nMeasurable growth in employee capability through training, cross-functional development, and succession planning.\nStrong coordination with Manufacturing, Quality Control, Validation, Engineering, and other functional partners.\nEffective support of client audits, regulatory inspections, remediation activities, and inspection-readiness efforts.\nSuccessful implementation of process improvements that strengthen compliance, efficiency, transparency, and team performance.\nAccurate and timely Quality KPI reporting, with clear communication of trends, risks, and corrective actions to leadership.\nDevelopment of a reliable and engaged team capable of independently managing routine Quality Systems responsibilities.\nThe hiring rate for this position is $76,00 - 95,000 annually 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), a flexible spending account, and a 401(k) plan..\n#LI-AC1\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":8878,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Health insurance","Insurance coverage"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-05T02:25:10Z"}],"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":"2026-11-08T10:45:15+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":4,"expected_fill_days":38,"reasons":["conf:8","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-supervisor-quality-systems","json_url":"https://alion.io/job/pci-pharma-services-supervisor-quality-systems.json","meta":{"generated_at":"2026-11-08T18:15:28Z","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":38295,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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-supervisor-quality-systems"},{"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-supervisor-quality-systems"},{"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-supervisor-quality-systems"},{"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-supervisor-quality-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-supervisor-quality-systems"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3783897}},{"tool":"search_jobs","arguments":{"company":"pci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3783897},"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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