{"id":2683893,"url":"https://alion.io/job/icu-medical-quality-supervisor","title":"Quality Supervisor","company":{"id":11675,"name":"ICU Medical","domain":"icumed.com","url":"https://alion.io/company/icu-medical","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":37,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":78000,"max_usd":148000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"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":"2026-10-13T15:50:51Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-31T23:41:44Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"Position Summary:\nThe Quality Supervisor leads and directs the Change Control, GxP Auditing, and Supplier Quality groups. This role ensures all site Change Control, Documentation, GxP Auditing, and Supplier Quality adhere to domestic and global GxP regulatory standards, company policies, and customer requirements. The supervisor will mentor staff, drive risk-based methodologies and continuous improvement initiatives, act as a Subject Matter Expert (SME) during regulatory inspections and foster a culture of quality and collaboration across departments to achieve operational excellence.\nEssential Duties & Responsibilities:\nSupervise the change control, documentation GxP audits, and supplier quality systems.\nEnsures GMP changes are consistent with established policies, procedures, and cGMPs.\nProvides quality oversight and guidance for managing changes, ensuring consistency and clarity throughout the process.\nEnsures site changes relating to Austin processes are reviewed for impact and Austin commitments are appropriately tracked to completion.\nEnsures consistency and compliance of changes with regulatory requirements (FDA CFR, Health Canada, ICH, etc.).\nEvaluates process/procedure/specification/drug changes as necessary. \nDrives continuous improvement of departmental processes.\nResponsible for quality reviews of validation records for local validated systems and processes; shared responsibility with quality groups.\nEnsures Change Control Review Board (CCRB) occurs at a specified frequency to discuss and make decisions on change control content, deliverables and any issues that arise.\nGuides decisions on risk and classifications of change control records and change control deliverables required to complete a required change.\nLeads the Plant QA Specialists for review and approval of product, process, labeling, facilities, utilities and equipment related SOPs, specifications, and drug changes.\nProvides supervision, leadership, training, and mentoring for guiding decisions and technical oversight for daily activities of the department. \nLeads GxP Audit team with improving the internal audit program and schedule.\nProvides guidance to audit teams (Internal/External), handling non-conformances, ensuring compliant documentation, staying current on regulations, and preparing for inspections.\nEnsures quality compliance and assurance processes related to suppliers and ensuring that all incoming materials and regulatory processes meet the Company’s quality standards. \nLeads Supplier Quality team with evaluating and selecting suppliers based on quality performance, capabilities, and risk assessments.\nProvides guidance and oversight to the Supplier Quality team for developing supplier quality strategies, directing supplier audits, managing supplier relationships, assessing quality agreements, assessing the ASL, and collaborating with cross-functional teams to drive continuous improvement initiatives.\nParticipates in the creation, implementation, and qualification of current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines.\nMay evaluate supplier exception reports and proposed Supplier Change Notifications, to determine the impact to the supplier material and compliance. When applicable, work with the supplier to determine resolution.\nMay conduct supplier risk mitigations for materials and commodities that do not meet specifications.\nMay assist with creation of the annual supplier audit schedule and company audit schedule and any amendments necessary.\nMay provide direction and support for market field actions such as product recalls, field alerts, and market withdrawals when action involves supplier or Third-Party Manufactured product, material, or commodity defect.\nMay review and approve supplier validation and qualifications packages for approval to the company’s Approved Supplier List.\nDevelop and implement quality metrics to monitor supplier performance.\nCompiles and assesses site metrics for inclusion into Management Review.\nDrive initiatives such as root cause analysis and corrective action plans for quality issues.\nPrepare quality reports for management, highlighting trends and areas of concern.\nProvide leadership, and development for all aspects of department programs for change control, documentation, supplier quality, and auditing programs including internal audits, process audits, and Good Manufacturing Practice (GMP) inspections.\nProvide coaching and direction to ensure consistent execution and professional development.\nEstablish and maintain budgets and expenditures for the area of responsibility.\nCome to agreement by managing communications through discussions and compromise.\nInvestigate exceptions related to the documentation or change control processes to determine root cause and appropriate corrective action(s).\nWrite or assist with the writing of Standard Operating Procedures.\nParticipate, manage, or lead special or strategic projects or initiatives in support of the business as required.\nPerform other related duties as assigned or required.\nKnowledge, Skills and Experience:\nThorough understanding of Pharmaceutical Quality Systems and Subsystems.\nThorough knowledge and understanding of cGMPs, FDA, Health Canada, ISO, ICH and/or pharmaceutical industry guidelines. \nDirect experience reviewing and approving changes, deviations, corrective and preventive action plans, and efficacy checks for GMP changes, audit and inspection-related records and documents. \nDirect experience with change control and documentation\nExperience with external suppliers and third-party manufactures.\nPrior experience with compliance assessments, audits, and inspection process.\nHigh level of attention to detail and the ability to prioritize and manage complex and heavy workloads in a dynamic environment. \nEffective skills collaborating with various teams and stakeholders, including quality, manufacturing, regulatory, and research and development, for effective change management.\nMust have strong analytical and problem-solving skills to address complex issues related to change control. \nMust have good organizational, presentation, project management, communication, technical writing, and meeting facilitation skills.\nExperience with QMS systems\nUnderstanding of investigation techniques including problem solving methodology (5 Whys, DMAIC, etc.). \nMust have proven experience with various computer software applications to track and trend quality metrics.\nMust demonstrate good interpersonal skills as well as a strong general business aptitude and ethics. \nMust be able to utilize logic to influence others at all levels within the organization. \nMust possess strong organizational and problem-solving skills.\nMust have strong written and verbal communication skills. \nMust be able to work and adapt in a fast-paced environment.\nExtensive knowledge of auditing principles, methodologies, and best practices.\nProficient in gap assessments, audit planning, and identifying compliance risks.\nExtensive knowledge of internal auditing principles, methodologies, and best practices.\nFamiliarity with global regulatory agency trends, notified body requirements, and systemic improvement processes.\nMinimum Qualifications, Education and Experience:\nBachelor’s degree STEM (Science, Technology, Engineering, Mathematics) from an accredited college or university is required.\n5-7 years of Quality compliance experience (Pharmaceuticals, Biopharmaceuticals or Biologics) across functions such as engineering, manufacturing, regulatory, quality, R&D in an FDA regulated industry. \nMinimum of two (2) years supervisory experience.\nCreation or operations experience in a wide variety of change control systems is preferred.\nMust be at least 18 years of age.\nMust pass pre-employment drug screen and background check. \nTravel Requirements:\nSite based role with travel for audits expected less than 15% of the time.\nPhysical Requirements and Work Environment:\nThis is largely a sedentary role. \nThis job operates in a professional office environment.\nWhile performing the duties of this job, the employee may be required to sit or stand for long periods of time.\nThe Quality Assurance Supervisor will interact regularly with engineering, production, supply chain, and external suppliers, and may occasionally travel for supplier audits or training.\nOccasional lifting to 25 lbs.","description_format":"text","description_chars":8469,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-16T07:12:48Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 20 · green card filings: 11","filings_12m":20,"filings_prev_12m":22,"green_card_filings_12m":11,"median_offered_wage_usd":125726,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of 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