{"id":3236086,"url":"https://alion.io/job/sandoz-head-technical-development-quality-bio-small-molecules-mwd","title":"Head Technical Development Quality Bio & Small Molecules (m/w/d)","company":{"id":453557,"name":"Sandoz","domain":"sandoz.com","url":"https://alion.io/company/sandoz-3","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":81,"open_postings":38,"ghost_share":0,"stale_share":0.947,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Leadership","role_family":"Leadership","seniority":"staff","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Holzkirchen, Germany"],"countries":["DE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":111580,"max":207220,"currency":"EUR","period":"year","gross":null,"usd_annual":232175},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-28T20:49:23Z","board_verified":true,"closed_at":null,"days_open":36,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":36},"description":"Job Description Summary\nLead Technical Development Quality for Sandoz Small Molecule and Biosimilar development programs, providing strategic quality oversight for both internal and external development activities across the product lifecycle. Ensure compliance with global regulatory requirements and Sandoz quality standards for Drug Substance and Drug Product development, including process development, manufacture, release of registration batches, and clinical supply through product launch. Partner closely with cross-functional teams to embed quality principles into development operations, drive proactive risk management, and support informed business decision-making. Represent Quality on project review boards, ensuring that compliance considerations and quality risks are effectively assessed, communicated, and integrated into development strategies and project execution.Job Description\nYour Key Responsibilities:\nTechnical project governance & compliance:\nDefine Sandoz Technical Development Quality Strategy with a key focus on both Small Molecules and Biosimilars development activities.\nDrive continuous improvement by contributing to Strategic Quality Planning and Risk Management e.g. via Quality/ Data Integrity Plan\nEnsure QA Compliance to applicable regulatory requirements for both Small Molecules and Biosimilars Product and Analytical Development activities both in-house and externally\nDrive quality integration of new parts of the SGD organization, especially in the course of building up Sandoz’ inhouse development capabilities in the area of Biosimilars (e.g. new in-house development center, acquisition of new SDC sites, …)\nEstablish adequate governance mechanisms to monitor QA compliance of development activities, define and implement CAPAs in case of deviations\nEstablish and drive compliance remediation programs in case major needs for improvement are identified\nSupport major acquisition projects, due diligence activities and organizational changes to ensure QA compliance at any time\nManage the resolution of GMP issues and significant deviations and investigations. Ensure senior management is notified of significant GMP events through the escalation process,\nEnsure continuous inspection readiness and timely implementation of CAPA plans, supporting/supervising the communication to Health Authorities linked to all product and analytical development activities of Sandoz\nOwn inspection and audit preparation incl. the follow-up in particular for PAI and Mock-PAIs e.g. thru on-site support, compliance assessments and site visits upfront\nSee the bigger picture and drive pro-active compliance and sustainable operational efficiency as contribution to project success (Gx mindset)\nWork with the business functions to develop KQIs that guide business decisions\nDefine and report KQIs/KPIs for Technical Development Quality network\nEnsure and provide guidance on Data Integrity and eCompliance\nPeople, Culture & Leadership:\nLead a team of SDC QA Heads in various locations around the globe within Sandoz Global Development.\nEnsure adequate staffing, technical competence and skill set as well as drive organizational and people development in all areas of responsibility.\nEnsure the definition of clear targets and objectives for all team members.\nEnsure regular Quality Management Reviews in all major parts of the organisation and define corrective and preventative measures in case required\nIdentify resource and skill gaps, subsequently:\no Recruit staff as required\no Support the team in their personal development and in determining training needs\nStrive to consistently uphold Sandoz´s core values\nExecute other duties as required by the Operational and/ or Functional Supervisor\nAdhere to Sandoz values and behaviours in line with the generic mindset and Sandoz company culture\nWhat you’ll bring to the role:\nGraduate in Chemistry, Pharmacy, Microbiology or Biotechnology, Engineering, Physics, or another related science\nFluent English required (oral & written)\nMinimum 10-15 years of experience within the pharmaceutical industry, e.g. in Quality Assurance, Quality Control, Pharmaceutical Development, Production\nGood understanding and knowledge of health authority requirements, Quality standards and policies in Drug Substance/Drug Product related to the main markets (North America, Europe, Japan).\nExperience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).\nExperience in Technical Operations and Medical Devices development/ manufacturing/ maintenance and respective regulations - MDR, ISO 13485 and 21 CFR 3, 4, 11, 210/211, 820, is a plus.\nProven track record in successfully leading international teams - strong communication and leadership skills. Prepared to manage the resources at disposal.\nExperience in managing external partners - strong collaboration skills: creating mutual trust and respect, analyzing problems/ issues, finding solutions, and reaching a consensus.\nQuality mind-set, always looking for improvement and best practice\nBusiness and customer focused, able to see the broader influence/ big picture and impact of QA on the organization, sense of urgency\nAbility to work independently, to prioritize, to address multiple issues\nMotivated by challenge\nAs part of your application, please submit your current CV as well as proof of your highest educational qualification (e.g., diploma, master’s degree, doctorate). Additional documents such as employment references may be uploaded optionally but are not mandatory.\nCompensation Structure & Criteria: \nSandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.\nJob location: Holzkirchen, Germany \nStarting pay range: EUR 111,580 - 207,220 \nComplimentary compensation: Monthly car allowance eligibility \nVariable compensation: 25% performance-based bonus, performance based long-term incentive plan. \nAdditional benefits include: 30 vacation days per year (in full time), 1.200€ vacation payment (in full time), €40/month in capital-forming benefits (in full time), company pension, flex-hybrid working 50% per week in the office, access to our learning & development platforms Skillsoft & Learnlight, Access to our employee share program “OurShare” \nPay frequency: Monthly \nExpected weekly working hours: 40 hours \nContract type: full time\nWhy Sandoz?\nSandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.\nWith investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.\nOur momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!\nJoin us, help us make healthcare fairer and faster.\nCommitment to Diversity & Inclusion:\nWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.\nHiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.\nThe law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.\n#Sandoz \nSkills Desired\nAgility, Agility, Business Acumen, Business Partnering, Business Strategy, Clinical, Clinical Trials, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, Inspection Preparedness, Knowledge Of Gxp, Leadership, Organizational Savvy, People Management, Problem Solving Skill, Qa (Quality Assurance), Quality Management, Research, Risk Management, Self-Awareness {+ 3 more}","description_format":"text","description_chars":8978,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Equity","Hybrid work"],"hiring_locations":[{"name":"Germany","iso":"DE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Pharmaceutical Distribution"],"lifecycle":[{"event":"open","at":"2026-10-25T11:44:07Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.451,"p_room":0.35,"age_days":35,"expected_fill_days":15,"reasons":["conf:9","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":232175,"is_top_pay":true},"html_url":"https://alion.io/job/sandoz-head-technical-development-quality-bio-small-molecules-mwd","json_url":"https://alion.io/job/sandoz-head-technical-development-quality-bio-small-molecules-mwd.json","meta":{"generated_at":"2026-10-29T01:17:21Z","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":1837,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":453557},"rest":"https://alion.io/mcp/rest/get_company?id=453557"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsandoz-head-technical-development-quality-bio-small-molecules-mwd"},{"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%2Fsandoz-head-technical-development-quality-bio-small-molecules-mwd"},{"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%2Fsandoz-head-technical-development-quality-bio-small-molecules-mwd"},{"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/sandoz-head-technical-development-quality-bio-small-molecules-mwd\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsandoz-head-technical-development-quality-bio-small-molecules-mwd"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3236086}},{"tool":"search_jobs","arguments":{"company":"sandoz.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3236086},"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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