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:

• 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 pro