Head Technical Development Quality Bio & Small Molecules (m/w/d)
Sandoz
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Benefits offered by this job
Job summary
Sandoz is seeking Head Technical Development Quality Bio & Small Molecules to lead QA governance across small molecules and biosimilars, ensuring regulatory compliance and inspection readiness. You will drive continuous improvement, CAPA programs, and manage international teams and external partners to uphold quality standards.
The role requires deep regulatory knowledge, experience with FDA/EMA inspections, and an ability to influence at the governance level while supporting impactful
Qualifications
- Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology, Engineering, Physics, or another related science.
- Fluent English required (oral & written).
- Minimum 10-15 years of experience in the pharmaceutical industry (QA, QC, Development, Production).
- Knowledge of health authority requirements and regulatory policies in major markets.
- Experience with Health Authority inspections (FDA/EMA) and RegCMC submissions.
Responsibilities
- Define and deliver QA governance and compliance for small molecules and biosimilars.
- Lead international QA teams and manage external partnerships.
- Drive continuous improvement, CAPA programs and inspection readiness.
- Oversee data integrity, eCompliance, and cross-functional quality metrics.
- Support major acquisition projects and due diligence from a QA perspective.
Skills
Education
Job description
- Define Sandoz Technical Development Quality Strategy with a key focus on both Small Molecules and Biosimilars development activities.
- Drive continuous improvement by contributing to Strategic Quality Planning and Risk Management e.g. via Quality/ Data Integrity Plan
- Ensure QA Compliance to applicable regulatory requirements for both Small Molecules and Biosimilars Product and Analytical Development activities both in-house and externally
- Drive 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, …)
- Establish adequate governance mechanisms to monitor QA compliance of development activities, define and implement CAPAs in case of deviations
- Establish and drive compliance remediation programs in case major needs for improvement are identified
- Support major acquisition projects, due diligence activities and organizational changes to ensure QA compliance at any time
- Manage the resolution of GMP issues and significant deviations and investigations. Ensure senior management is notified of significant GMP events through the escalation process,
- Ensure 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
- Own 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
- See the bigger picture and drive pro-active compliance and sustainable operational efficiency as contribution to project success (Gx mindset)
- Work with the business functions to develop KQIs that guide business decisions
- Define and report KQIs/KPIs for Technical Development Quality network
- Ensure and provide guidance on Data Integrity and eCompliance
- Lead a team of SDC QA Heads in various locations around the globe within Sandoz Global Development.
- Ensure adequate staffing, technical competence and skill set as well as drive organizational and people development in all areas of responsibility.
- Ensure the definition of clear targets and objectives for all team members.
- Ensure regular Quality Management Reviews in all major parts of the organisation and define corrective and preventative measures in case required
- Identify resource and skill gaps, subsequently:
- Recruit staff as required
- Support the team in their personal development and in determining training needs
- Strive to consistently uphold Sandoz´s core values
- Execute other duties as required by the Operational and/ or Functional Supervisor
- Adhere to Sandoz values and behaviours in line with the generic mindset and Sandoz company culture
- Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology, Engineering, Physics, or another related science
- Fluent English required (oral & written)
- Minimum 10-15 years of experience within the pharmaceutical industry, e.g. in Quality Assurance, Quality Control, Pharmaceutical Development, Production
- Good 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).
- Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
- Experience 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.
- Proven track record in successfully leading international teams – strong communication and leadership skills. Prepared to manage the resources at disposal.
- Experience in managing external partners – strong collaboration skills: creating mutual trust and respect, analyzing problems/ issues, finding solutions, and reaching a consensus.
- Quality mind-set, always looking for improvement and best practice
- Business and customer focused, able to see the broader influence/ big picture and impact of QA on the organization, sense of urgency
- Ability to work independently, to prioritize, to address multiple issues
- Motivated by challenge
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.
- Starting pay range: EUR 111,580 - 207,220
- Complimentary compensation: Monthly car allowance eligibility
- Variable compensation: 25% 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.
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.
Diversity and Inclusion
Division
SANDOZ
Business Unit
Quality
Location
Germany
Site
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