{"id":1929486,"url":"https://alion.io/job/pci-manager-compliance","title":"Manager, Compliance","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":null},"role":"Legal","role_family":"Legal","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":106800,"max":120150,"currency":"USD","period":"year","gross":null,"usd_annual":120150},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-22T00:00:00Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-10-12T02:20:51Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"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 Manager, Compliance leads a team responsible for audit inspection readiness and quality audit policies & procedures in support of PCI Pharma’s clinical and commercial manufacturing facilities. This role oversees quality management system (QMS) activities such as risk assessments, audit follow-ups, and client contractual agreements to ensure compliance with U.S. and international regulatory requirements.\nESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:\nManages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs.\nDevelops technical acumen and decision-making skills in direct reports.\nOversees PCI Pharma’s risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders.\nLeads complex audit, deviation and CAPA investigations.\nIn collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality.\nManages quality event trend reports and metrics to measure key quality attributes.\nAccountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations.\nDevelops and maintains relevant quality sections of contractual agreements with clients.\nRegular and reliable attendance on a full time basis [or in accordance with posted schedule].\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’s cultural values and aligns daily actions with department goals and company culture.\nEDUCATION AND EXPERIENCE:\nBachelor’s degree in a Life Sciences or Engineering discipline, or equivalent.\nMinimum of 7 years of relevant QA experience in a regulated industry; biotech or pharmaceutical industries strongly preferred.\nMinimum of 3 years of leadership or supervisory experience.\nExperience with aseptic processing; experience with restricted access barrier systems (RABS) and isolators preferred.\nWorking knowledge of cGMPs, FDA regulations, ICH Guidelines in drug/device, and familiarity with the European Community guidelines for cGMPs.\nAdvanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.\nKnowledge and hands on experience with QMS data management software such as Track Wise, Master Control, ETQ, etc.\nExperience with process mapping, data analysis and presentation software such as Visio, Microsoft office, Excel, PowerPoint, etc. \nLEADERSHIP RESPONSIBILITIES:\nDirects and provides expert knowledge in the day-to-day function of QA Compliance.\nIdentifies, recruits, and retains top-notch talent.\nChampions PCI Pharma’s culture and empowers employees to take responsibility for their jobs and goals.\nCoaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.\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, and appropriate email, and regular interpersonal communication.\nProvides oversight and direction to the employees in accordance with PCI Pharma’s policies and procedures.\nThe hiring rate for this position is $106,800 - $120,150.00 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.\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":5683,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Health insurance","Insurance coverage"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Clinical Trial Services (CRO)","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-05T21:20:39Z"}],"visa":[],"liveness":{"score":72,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.8,"p_room":0.9,"age_days":18,"expected_fill_days":29,"reasons":["conf:1","velocity","win:mid","comp:brand"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":120150,"is_top_pay":false},"html_url":"https://alion.io/job/pci-manager-compliance","json_url":"https://alion.io/job/pci-manager-compliance.json","meta":{"generated_at":"2026-10-12T02:55:26Z","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":4391,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":1987116},"rest":"https://alion.io/mcp/rest/get_company?id=1987116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpci-manager-compliance"},{"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%2Fpci-manager-compliance"},{"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%2Fpci-manager-compliance"},{"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-manager-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-manager-compliance"}]}