Job Description Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Sandoz Quality Management Systems.Job Description
Job Description:
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Manage portfolio of projects.
- Create and review GMP relevant documents in own area of responsibility (e.g. batch records for material manufactured and packaged internally, SOPs, procedures, records, third party work)
- Negotiate and clarify deficiencies in GMP documents in area of own responsibility with the
- line unit.
- Provide support to internal policies (GOPs, Manual), and global compliance initiatives.
- Develop and improve GMP processes to meet internal and external guidelines regarding
- quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE etc.).
- Organize, coordinate Pest Control program tasks. Supervise external partners for pest control.
- Act in role of Investigator or QA representative for Deviations.
- Prepare reports and risk assessments in area of responsibility.
- Promote and enforce compliance to guidelines.
- Perform walkthroughs on shopfloor
- Responsible as first line of QA-support for shopfloor
- Support inspections and audits and perform self-inspections and audits if applicable.
- Responsible for BRR and coordination of batch release.
- Support artwork changes as respective quality role.
- Responsible for Deviations and Complaints as QA representative.
- Management of quality data in SAP
- Support all quality-related activities in Development to ensure compliance with the systems and policies
- Support the implementation and monitor quality upgrade programs within development
- Support, implement and monitor quality-related global tools, processes and standards (e.g. GOPs, Novartis Quality Manual etc.)
- Ensure review and approval of quality-related documents (e.g. Specifications, validation protocols and reports etc. according to QCM Responsibility & Signature List)
- Support & guidance to project teams to ensure quality output
- Support transfers from/to development
- Provide support in all development items for deficiency letter answering
- Degree in scientific or relevant discipline
- At least 2 years experience in a GMP approved quality control laboratory
- Preferably 4 years work experience in GMP environment, preferably in different areas (e.g. QA, Production, Process development, Reg. Affaires)
- At least 2 years’ experience in product development and analytics and/or quality control and/or quality assurance with knowledge in product management
- Thorough knowledge of cGMP, national pharmaceutical legislation and regulatory guidelines
- Adequate presentation and scientific/technical writing skills
- Advanced organizational and communication skills
- Knowledge of software and computer tools relevant for pharmaceutical development
- Fluent in German-language (oral and written)
- Good in English (oral and written)
As 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.
Compensation Structure & Criteria:Sandoz 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.
- Job location: Holzkirchen, Germany
- Starting pay range: EUR 54,100 - 100,500
- Variable compensation: 5% performance-based bonus, performance based long-term incentive plan.
- Additional 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”
- Pay frequency: Monthly
- Expected weekly working hours: 40 hours
- Contract type: full time
Sandoz 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.
With 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.
Our 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!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The 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.
#Sandoz
Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological IntelligenceSkills Required
- Degree in scientific or relevant discipline
- At least 2 years experience in a GMP approved quality control laboratory
- Preferably 4 years work experience in GMP environment (QA, Production, Process Development, Regulatory Affairs)
- At least 2 years' experience in product development and analytics and/or quality control and/or quality assurance with product management knowledge
- Thorough knowledge of cGMP, national pharmaceutical legislation and regulatory guidelines
- Adequate presentation and scientific/technical writing skills
- Advanced organizational and communication skills
- Knowledge of software and computer tools relevant for pharmaceutical development
- Experience managing quality data in SAP
- Fluent in German (oral and written)
- Good English (oral and written)
Sandoz Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.
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Healthcare Strength — Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
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Retirement Support — A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
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Equity Value & Accessibility — Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.
Sandoz Insights
What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
