{"id":3999580,"url":"https://alion.io/job/alk-gxp-system-specialist","title":"GxP System Specialist","company":{"id":4505083,"name":"ALK","domain":"alk.dk","url":"https://alion.io/company/alk-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Denmark"],"countries":["DK"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-08T23:00:00Z","employer_posted_date":null,"last_verified_at":"2026-11-08T23:00:00Z","board_verified":false,"closed_at":null,"days_open":1,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":1},"description":"Are you experienced with Application Lifecycle Management system and GxP automation? Do you thrive in a global environment and want to advance your career withing life sciences? If so, we invite you to keep reading.\n\n**Your Role As GxP System Specialist\n\n**You will join the ALK Global Business IT Business Application Systems (BAS) department as process owner for Application Lifecycle Management system and GxP automation. In ALK, we use OpenText ALM for Application Lifecycle Management and OpenText UFT for GxP automation.\n\n**Responsibilities\n\n**In this role, you will combine strong process ownership with hands-on system and tooling expertise to drive improvement and innovation in a GxP enviroment, your Key Responsibilities include:\n\nOwn and continuously improve ALK's Application Lifecycle Management system (OpenText ALM), ensuring it remains compliant, efficient, and fit for purpose as regulatory and business needs evolve.\n\nSupport computer system validation (CSV) activities for ALK’s automation and test-automation solutions (OpenText UFT) that fall within GxP scope, applying a risk-based approach throughout.\n\nDrive the creation and maintenance of QMS-related SOPs and Work Instructions for OpenText ALM and OpenText UFT, keeping documentation current with regulatory expectations.\n\nProactively identify and manage improvement opportunities across Global IT systems, including expanding automated and computer-aided testing to increase coverage and efficiency.\n\n**It is preferred that the candidate has solid knowledge of compliance, so the candidate can also take further responsibilities include:\n\n**\n\nLead the GxP compliance framework for projects and releases across ALK's Veeva Vault portfolio, coordinating impact assessments and validation activities.\n\nSupport the handling of Deviations, CAPAs, and Change Controls for systems owned by our department, ensuring timely and well-documented resolution.\n\nAssist in representing Business Application Systems during internal and external inspections and audits, preparing and presenting validation and automation evidence.\n\n**Your qualifications to enable you to succeed in this role:\n\n****IT Qualifications\n\n**\n\nBachelor’s or master’s degree in computer science, Engineering, or a related field.\n\n3+ years of professional experience within pharmaceutical or other GxP-regulated industries.\n\n3+ years of hands-on experience with Computer System Validation (CSV) and GxP compliance requirements.\n\nSolid, hands-on experience with ALM (Application Lifecycle Management) is required.\n\nExperience with Veeva Vault QualityDocs and Veeva Vault RIM is an advantage.\n\n**General Qualifications\n\n**\n\nQuick learner with a genuine interest in new applications and technologies.\n\nInnovative mindsets paired with a pragmatic, can-do attitude.\n\nA structured, quality-first mindset is essential, with the ability to follow and document processes in line with ALK's quality standards.\n\nProficiency in both written and spoken English.\n\nProven ability to collaborate effectively and thrive in an international environment, with colleagues located in Hørsholm, Madrid, and Krakow.\n\nFlexibility to travel up to 10 days per year, primarily within Europe.\n\n**World Leader In Allergy\n\n**ALK’s goal is to become the global leader in allergy care by helping many people live better lives through prevention, diagnosis, and treatment options. In Global IT, we play a key role in this mission by supporting the organization with cutting-edge IT tools and technologies, and by providing world-class support to our colleagues around the world.\n\n**Global IT At ALK\n\n**Global IT at ALK is a diverse, international team of approximately 140 employees, with key hubs in Hørsholm, Madrid, and Krakow, along with IT staff at production sites and regional sales hubs in Germany, France, and North America. ALK predominantly manages its IT expertise in-house, offering you the chance to collaborate with talented colleagues from around the world.\n\nWe believe that achieving outstanding results and delivering exceptional IT services go hand in hand fostering development and learning opportunities. Our employees are encouraged to connect and support each other daily. You will join an IT organization that values competence and substance over style and presentation, and that thrives on collaborative, iterative teamwork.\n\n**We look forward to hearing from you!\n\n**Are you experienced with Application Lifecycle Management system and GxP automation? Do you thrive in a global environment and want to advance your career withing life sciences? If so, we invite you to keep reading.\n\nAllergy impacts and challenges the lives of millions of adults and children every day. At ALK, our purpose is to improve the lives of people living with allergies. Building on our strong heritage, we are guided by our strategy, Allergy+, that shows us a clear path towards this goal through focus, innovation, cultivation and optimisation.\n\nRead more about our corporate strategy and our ambitions for growth\n\n**Fair and unbiased recruitment at ALK\n\n**At ALK, we believe that every candidate deserves to be evaluated fairly and respectfully. Our recruitment process is designed to give each applicant an equal opportunity, regardless of their background. Read more about fair and unbiased recruitment at ALK.\n\nIf you are applying from North America, please know that we are committed to fair, unbiased and non-discriminatory recruitment practices and to complying with all applicable federal, state and local employment laws. Employment decisions are made based on qualifications, skills and experience, without discrimination on the basis of legally protected characteristics. For more information, please visit the official websites of the relevant authorities: U.S. Equal Employment Opportunity Commission (EEOC) and Office of Federal Contract Compliance Programs (OFCCP).\n\n**Your recruitment journey at ALK\n\n**Curious to learn more about our recruitment process? Please visit this page.","description_format":"text","description_chars":6003,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Germany","iso":"DE","kind":"country"},{"name":"France","iso":"FR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-10T02:52:15Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":24,"reasons":["seen:1","win:early"],"computed_at":"2026-11-10T05:52:01Z"},"pay":null,"html_url":"https://alion.io/job/alk-gxp-system-specialist","json_url":"https://alion.io/job/alk-gxp-system-specialist.json","meta":{"generated_at":"2026-11-10T05:52:01Z","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":13608,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"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":4505083},"rest":"https://alion.io/mcp/rest/get_company?id=4505083"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falk-gxp-system-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Falk-gxp-system-specialist"},{"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%2Falk-gxp-system-specialist"},{"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/alk-gxp-system-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falk-gxp-system-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3999580}},{"tool":"search_jobs","arguments":{"company":"alk.dk","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3999580},"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"}}