About the Role

We are currently seeking a CSV & Data Integrity (DI) Squad Lead. In this role, you will co-lead, together with Local Process Owners, the effort to align all CSV and DI initiatives at the site with current industry best practices. This includes the dimension of risk management.

Key Responsibilities

• Provide expert guidance on CSV and DI best practices, ensuring alignment with modern risk-based approaches
• Oversee multiple projects, including managing external resources (contractors), ensuring timely and effective delivery
• Ensure quality and regulatory in collaboration with the corresponding QA lead to assure full alignment
• Lead change management efforts to embed best practices across the organization
• Coach and mentor Local Process Owners to elevate their knowledge and implementation of industry best practices

• Strong expertise in CSV and DI within a pharmaceutical manufacturing context
• Experience with API environments preferred
• Familiarity with systems such as DeltaV, PI, PCS7 along with practices as effective alarm management
• In-depth knowledge of FDA and EMA requirements related to CSV and DI
• Practical experience with risk-based validation and the preparation of validation documentation
• Proven project management abilities: planning, coordination, and delivery
• Strong interpersonal and communication skills
• Experience in leading teams in complex and dynamic environments
• Skills in coaching, training, and human change management
• Ability to navigate organizational dynamics and influence without formal authority
• Fluent in English, both written and spoken, Dutch is a plus