{"id":4206131,"url":"https://alion.io/job/keenova-quality-manager","title":"Quality Manager","company":{"id":1880265,"name":"Keenova","domain":"keenova.com","url":"https://alion.io/company/keenova","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":4,"ghost_share":0,"stale_share":0.75,"repost_share":0,"time_to_fill_p50_days":39,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-11-12T23:44:40Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T23:44:40Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Job Title\nQuality Manager Requisition\nJR000016106 Quality Manager (Open)Location\nMadison, WIAdditional Locations\nJob Description Summary\nThe Quality Manager is responsible for providing Quality leadership and support to the site. This role works closely with the Director, Quality to maintain a proactive approach to system and functional area compliance requirements. The role is a critical link between cross functional groups that include regulatory affairs, engineering, materials management, quality control, and manufacturing. The position must maintain and develop collaborative approaches to drive improvement and meet compliance. This role plays a key role in creating and maintaining a culture of quality, compliance, safety, and service. This position manages quality assurance and quality control roles at the site and acts as a mentor to team members. This position will operate independently and provide clear direction on the abilities to support projects, production, and other site level and compliance activities.Job Description\nKey Responsibilities:\nEnsure personnel and work environment operate safely, ensuring EHS practices are followed.\nDevelop, coach, and mentor site personnel in order to improve bench strength within the organization and create an environment of growth to improve and build on the quality culture. \nManage the implementation and maintenance of quality assurance systems and activities, ensuring compliance to site and corporate policies, applicable regulations and providing strategic and technical input for standard and best practices for regulatory compliance. This includes oversite of the site CAPA processes and Management Review presentations.\nLead the site supplier quality management processes, including participation in supplier selection, auditing, assessment, and investigation/corrective actions\nManage Quality Assurance and Quality Control personnel to ensure all aspects of engineering, manufacturing operations and quality are fully supported to meet compliance and business expectations.\nManage the generation, review, and archival of documents and records used to support current Good Manufacturing Practice. \nLead management of and approve CAPA, complaint, investigation, audit, Change Control, and deviation systems records, ensuring timely resolution of these records to meet compliance and business expectations.\nManage the site Quality Engineering function to facilitate effective issue investigation, root cause determination, and proposed corrective actions\nSupport management of or manage quality system training program, ensuring comprehension and compliance of procedures throughout cross functional areas at the site.\nUse critical thinking skills to bring solutions to quality and technical topics such as investigations, root cause analysis, and risk management tools.\nInterface with peers at other sites to propagate best practices to:\nWrite, revise, review and approve standard operating procedures and work instructions\nDevelop and generate quality system metrics for tracking and trending purposes and recommend actions as appropriate.\nMake data driven and highly technical decisions that support compliance and site quality policy.\nDevelop and maintain site audit programs (regulatory, external, and internal).\nProvide/review/approve information to support regulatory filings, including responses to inquiries, review of CMC, labeling review, etc.\nParticipate as a leader in regulatory inspections.\nIndependently lead critical compliance activities.\nMay perform additional duties as required and assigned by management, including duties that support overall company initiatives.\nQualifications:\nEducation/Experience/Preferred Skills\nBachelor’s degree in a scientific discipline or equivalent or\nBachelor’s degree and a minimum of 8 years of experience in a cGMP environment (pharmaceuticals and medical device industries)\nAt least 4 years in a Quality Assurance function within a cGMP environment with demonstrated experience in product Quality from clinical supply to commercial manufacturing, including implementation of new processes across functional groups. \nAt least 5 years of supervisory/people leadership experience.\nCompetencies\nExcellent interpersonal, communication and presentation skills.\nExcellent organization and project management skills.\nStrong critical thinking, problem solving and decision-making skills, with ability to trend data. \nWorking knowledge of cGMPs and regulations including experience hosting or facilitating regulatory inspections.\nExperience with Design Quality Validation and Verification is preferable\nAbility to travel (5-10%).\nRobust understanding of ISO9001, ISO13485, MDSAP regulations\nOrganizational Relationship/Scope:\nThe Quality Manager collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, Engineering, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Director, Quality. It is the expectation this position works onsite at a manufacturing facility during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.\nWorking Conditions:\nThe Quality Manager will mainly work in an office environment onsite at a manufacturing facility but may also be required to work in manufacturing and warehousing areas.\nKeenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova\nDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.\nAt Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.\nWe bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.\nWe are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.","description_format":"text","description_chars":6719,"description_truncated":false,"requirements":{"experience_years_min":8,"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":["Prescription Drugs"],"lifecycle":[{"event":"open","at":"2026-11-12T23:44:40Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":39,"reasons":["conf:2","win:early"],"computed_at":"2026-11-13T02:17:18Z"},"pay":null,"html_url":"https://alion.io/job/keenova-quality-manager","json_url":"https://alion.io/job/keenova-quality-manager.json","meta":{"generated_at":"2026-11-13T02:17:18Z","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":4821,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"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":1880265},"rest":"https://alion.io/mcp/rest/get_company?id=1880265"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkeenova-quality-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fkeenova-quality-manager"},{"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%2Fkeenova-quality-manager"},{"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/keenova-quality-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkeenova-quality-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4206131}},{"tool":"search_jobs","arguments":{"company":"keenova.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4206131},"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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