{"id":3603938,"url":"https://alion.io/job/csl-limited-associate-director-head-qa-compliance","title":"Associate Director, Head QA Compliance","company":{"id":723138,"name":"CSL Limited","domain":"csl.com","url":"https://alion.io/company/csl-5","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":36,"ghost_share":0,"stale_share":0.806,"repost_share":0,"time_to_fill_p50_days":32,"computed_at":"2026-11-05T05:54:30Z"}},"role":"QA","role_family":"QA","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Bern, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-02T10:51:38Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-06T03:44:08Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"The Role\nQuality systems and regulatory compliance are fundamental to ensuring patients can depend on safe, effective medicines. As Associate Director, QA Compliance, you will lead the implementation and continuous improvement of the site's Quality Management System, ensuring alignment with CSL standards and applicable GMP regulations. This is a senior leadership role with broad responsibility for quality governance, inspection readiness, risk management, and regulatory compliance, while partnering closely with global quality teams to drive consistency and excellence across the wider network.\nLocation: Bern, Switzerland\nWhy It Matters\nThis role sits at the centre of the site's quality and compliance framework. You will help ensure the ongoing effectiveness of the quality systems that support licensed manufacturing operations, maintain regulatory compliance, and safeguard inspection readiness. Through leadership of quality risk management, change control, audit activities, and quality performance monitoring, you will play a key role in ensuring the site continues to meet the highest standards expected by health authorities, patients and the business.\nWhat You'll Be Responsible For\nAs Associate Director, QA Compliance, you will provide strategic and operational leadership for site quality compliance activities while leading a team of quality professionals. You will drive quality performance, oversee critical quality systems, and work across local and global functions to ensure consistent application of quality standards and continuous improvement initiatives.\nLead the implementation and ongoing ownership of the site's Quality Management System in accordance with CSL standards and global regulatory requirements.\nMaintain site manufacturing and establishment licence requirements and ensure continued GMP compliance.\nChair the Site Change Control Panel and oversee Deviation Management, quality risk management processes, including maintenance of the Quality Risk Register.\nLead site preparation for regulatory inspections, customer audits, self-inspections, and internal audit activities while driving continuous inspection readiness.\nMonitor and improve quality performance through KPI management, trend analysis, Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and Quality Management Reviews.\nProvide leadership and direction to quality teams while partnering with Global Quality Systems and Compliance colleagues to strengthen and standardise quality processes across the network.\nExperience Required\nBachelor's degree or equivalent qualification in a relevant scientific or technical discipline.\nSignificant experience, typically 10+ years, in quality assurance, quality systems, compliance, or a related pharmaceutical manufacturing environment.\nDeep expertise in pharmaceutical quality systems, quality management processes, GMP/GxP compliance, and regulatory requirements including ANNEX-1.\nDemonstrated experience managing health authority inspections e.g. Swissmedic, US FDA, NMPA China etc. associated regulatory interactions as well as customer audits.\nStrong knowledge of quality risk management, change control, Deviation Management, quality performance monitoring, and continuous improvement methodologies.\nProven leadership, stakeholder management, and influencing skills, with experience working across global, matrixed, multicultural environments highly desirable.\nTravel\nTravel may be required to support collaboration with global quality and compliance teams, audit and inspection activities, and cross-functional initiatives across the network.\nAbout CSL Behring\nCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.\nCSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.\nTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.\nOur Benefits\nFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.\nYou Belong at CSL\nAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.\nTo learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging\nEqual Opportunity Employer\nCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.","description_format":"text","description_chars":5509,"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":[],"hiring_locations":[{"name":"Switzerland","iso":"CH","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Vaccines","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-11-02T10:51:38Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":32,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/csl-limited-associate-director-head-qa-compliance","json_url":"https://alion.io/job/csl-limited-associate-director-head-qa-compliance.json","meta":{"generated_at":"2026-11-06T03:49:43Z","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":6470,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":723138},"rest":"https://alion.io/mcp/rest/get_company?id=723138"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcsl-limited-associate-director-head-qa-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%2Fcsl-limited-associate-director-head-qa-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%2Fcsl-limited-associate-director-head-qa-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/csl-limited-associate-director-head-qa-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcsl-limited-associate-director-head-qa-compliance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3603938}},{"tool":"search_jobs","arguments":{"company":"csl.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3603938},"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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