{"id":1556949,"url":"https://alion.io/job/american-regent-director-quality-control","title":"Director Quality Control","company":{"id":2011712,"name":"American Regent","domain":"americanregent.com","url":"https://alion.io/company/americanregent","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":78,"open_postings":8,"ghost_share":0,"stale_share":0.875,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Columbus, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":145000,"max_usd":262000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":407},"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Lighthouse","optional":false}],"status":"live","first_seen_at":"2026-09-16T00:00:00Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-25T07:21:17Z","board_verified":true,"closed_at":null,"days_open":40,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":40},"description":"Nature and Scope\nThis Director Quality Control is a member of the Quality Assurance team and is responsible for leading all laboratory activities in support of manufacturing and R&D. This position is responsible for leading the analytical, microbiology and environmental monitoring activities for a multi-site sterile manufacturing operation.\nEssential Duties and Responsibilities\nNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nManage the day-to-day activities in the laboratories in support of both operations and R&D functions as well as Environmental Monitoring Technicians in manufacturing at New Albany and Hilliard manufacturing Facilities.\nManage testing programs including analytical, sterility, bioburden and microbiological tests as necessary.\nManage, identify and introduce new testing methodologies for applicable testing procedures.\nManage and perform trend analysis for all operations.\nProvide support in front of regulatory agencies eg: FDA/ CDER-CBER, customer audits, corporate auditors, Health Canada, EMA, internal audits and as required\nSupervise the certification of laboratory technicians on various test procedures per USP, FDA, PDA and EU guidelines.\nHire, train and manage performance of existing and future laboratory personnel and technicians.\nWrite, review, and approve validation and qualification SOPs.\nProvide expertise in EMPQ qualifications, new sterile filler qualifications, new water systems qualifications, new laboratory space qualifications and disinfectant study qualifications.\nEnsure laboratories maintain compliance with cGMPs/GLPs, support validation, regulatory filing, R&D, Metrology, Engineering, QA, manufacturing and formulation operations.\nIdentify, evaluate, purchase and qualify laboratory equipment.\nDirect, perform and resolve out-of-specification investigations, deviations and implement CAPAs.\nHave knowledge of and support the Sterility Assurance Utilities process, Cleaning & Disinfection process and Traffic & Gowning process of sterile manufacturing.\nTrain, coach, mentor and supervise direct reports.\nOversee, trouble shoot and investigate outsourced testing for products and components.\nPartner with Production, Regulatory Affairs, Engineering, and QA Compliance to strategize and organize implementation of new technology, processes, and products.\nIdentify and facilitate process improvements to increase efficiencies in systems, operations, and personnel. \nEnsure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.\nPosition has responsibilities at multiple locations in central Ohio and provide input, as requested, with ARI Shirley, NY on microbiology issues.\nPerform any other tasks/duties as assigned by management.\nEducation Requirements and Qualifications\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.\nBachelors in Life Sciences required at Minimum. Advanced Degree in preferred.\nMinimum of 12 years of experience in pharmaceutical manufacturing industry required.\nMinimum 8 years management experience required. Exceptions may be considered for outstanding candidates with proven expertise.\nExperience with Trackwise for Deviations, CAPAs and CR process.\nExperience with Lighthouse, or equivalent, environmental monitoring systems, including implementation and operation.\nExperience with method development, in microbiology and/or analytical methods is desired.\nDemonstrated expertise managing cGMP laboratory.\nStrong knowledge of contamination control, disinfection, microbiology, sterility assurance, aseptic processing, cGMPs and regulatory requirements.\nStrong knowledge of MS-Office software and PC Skills required.\nExcellent leadership, communication, organizational, interpersonal and communication skills (oral and written).\nProven record of people and program management skills.\nAbility to work independently and deliver timely results.\nAbility to work off hours and weekends as needed.\nPhysical Environment and Requirements\nEmployee must be able to occasionally lift and/or move up to 25 pounds.\nPhysically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. \n\nAmerican Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.\nApplicants have rights under Federal Employment Laws.\nFMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf\n\nKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)\n\nEmployee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf\n\nAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:\n·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.\n·Our recruiting process includes multiple in person and/or video interviews and assessments.\n·If you are unsure about the legitimacy of a message, contact John Rossini at  before responding.\n·We never request payment, bank information, or personal financial details during our offer process.\nYour security is important to us, and we encourage you to stay vigilant when job searching.\nAmerican Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .","description_format":"text","description_chars":6175,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Dietary Supplements"],"lifecycle":[{"event":"open","at":"2026-10-01T02:23:40Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3 · green card filings: 1","filings_12m":3,"filings_prev_12m":3,"green_card_filings_12m":1,"median_offered_wage_usd":112500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":40,"band":"fade","label":"Fading","p_open":1,"p_active":0.731,"p_room":0.55,"age_days":39,"expected_fill_days":30,"reasons":["conf:3","win:tail"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/american-regent-director-quality-control","json_url":"https://alion.io/job/american-regent-director-quality-control.json","meta":{"generated_at":"2026-10-26T04:06:31Z","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":5665,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":2011712},"rest":"https://alion.io/mcp/rest/get_company?id=2011712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famerican-regent-director-quality-control"},{"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%2Famerican-regent-director-quality-control"},{"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%2Famerican-regent-director-quality-control"},{"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/american-regent-director-quality-control\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famerican-regent-director-quality-control"}]}