Head Technical Development Quality Bio & Small Molecules (m/w/d)

Sandoz

Holzkirchen

Hybrid

EUR 104,000 - 192,000

Full time

14 days+

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Benefits offered by this job

Monthly car allowance

30 vacation days per year

Vacation payment €1,200

Capital-forming benefits €40/month

Company pension

Flex-hybrid working 50% office

Job summary

Sandoz, Holzkirchen, Germany, seeks a seasoned Lead for Technical Development Quality to oversee QA for small molecules and biosimilars, ensuring regulatory compliance and strategic quality governance across development programs. The role partners across functions to embed quality, manage risk, and drive CAPA programs.

The successful candidate will have a strong QA background in pharma, experience with Health Authority inspections, and leadership of international teams, with a focus on

Qualifications

Graduate degree in a life science or engineering field with relevant pharma exposure.
Experience with health authority inspections (FDA/EMA) and RegCMC.
Knowledge of GMP, GxP and drug development regulatory requirements.

Responsibilities

Define and govern quality strategy for small molecules and biosimilars development.
Ensure regulatory compliance across drug substance/product development and manufacturing.
Lead QA activities, CAPA programs and risk management throughout product lifecycle.
Oversee inspection readiness and communicate with health authorities.
Staff development, resource planning and leadership of global QA heads.

Skills

Fluent English

International team leadership

Quality mindset

Problem solving

Regulatory knowledge

Communication skills

Education

Science degree

Job description

Job Description Summary

Lead 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

Your Key Responsibilities:

Technical project governance & compliance:

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

People, Culture & Leadership:

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

What you’ll bring to the role:

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

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 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

Why Sandoz?

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.

Skills Desired