{"id":2284231,"url":"https://alion.io/job/pci-pharma-services-director-compliance","title":"Director, 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":{"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":"Finance","role_family":"Finance","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":{"min_usd":113000,"max_usd":215000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2103},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-09-07T00:00:00Z","employer_posted_date":"2026-09-07","last_verified_at":"2026-10-30T13:23:00Z","board_verified":true,"closed_at":null,"days_open":53,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":53},"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.\nManages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs and the Annual Product Quality Review (APQR) program.\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.\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.\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.\nWhile performing the duties the employee is:\nconstantly required to sit, and to reach to use computers and other office equipment\nconstantly stand for extended periods of time, up to four (4) hours/time.\nrequired to gown into cleanrooms or into aseptic spaces on a regular basis\nfrequently required to lift up to 20 pounds\nconstantly required to view objects at close and distant ranges with hand and eye coordination\nfrequently required to communicate with others\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.\nRequires a minimum of a bachelor’s degree, with preference for those in life sciences, chemistry, engineering or other science disciplines. An advanced degree is desirable.\nApproximately 10+ years’ experience in a similar organization with at least five of those years in a management role, with the majority of this experience gained in an aseptic or sterile production environment. \nContract Manufacturing experience is a plus\nIndustry experience outside of Quality, as well as core experience in Quality is a plus\nRequires an advanced knowledge of global regulatory guidance in including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1) related to Quality Systems and Aseptic Manufacturing and testing. Ability to interpret other global regulations as necessary is required (e.g., WHO, ANVISA, etc). \nHands-on experience with QMS data management software (eQMS), process mapping tools, risk assessments, data analysis, and software for presentation of all of these is required. The ability to communicate the compliance status as well as measure it is paramount to success in this role. \nThe Director of Compliance will ensure the site is always prepared logistically for a Regulatory Inspection, recruiting, training and drilling personnel from throughout the site to fill all positions required in a regulatory inspection. The Director will generally serve as the host of the lead inspector. \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":6053,"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":"2026-10-11T12:57:54Z"}],"visa":[],"liveness":{"score":20,"band":"cold","label":"Long shot","p_open":1,"p_active":0.551,"p_room":0.36,"age_days":53,"expected_fill_days":34,"reasons":["conf:5","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-director-compliance","json_url":"https://alion.io/job/pci-pharma-services-director-compliance.json","meta":{"generated_at":"2026-10-30T15:00:59Z","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":2642,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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-pharma-services-director-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-pharma-services-director-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-pharma-services-director-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-pharma-services-director-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-director-compliance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2284231}},{"tool":"search_jobs","arguments":{"company":"pci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2284231},"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. Docs: https://alion.io/developers"}}