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

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:

o Recruit staff as required

o 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

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 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.

#Sandoz

Skills Desired

Agility, 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}