Overview
Our client operates in the biopharmaceutical field and focuses on advanced cell‑based therapies for patients with severe and complex diseases. The organization combines cutting‑edge science with large‑scale operations in a highly regulated environment. To support continued growth and innovation, they are looking for a Senior Manager Validation to lead critical quality and compliance activities.
Responsibilities
- Lead daily validation operations covering equipment, utilities, facilities, and systems.
- Oversee multiple CQV projects, tracking progress, risks, and delivery timelines.
- Maintain and update the site validation master plan, including requalification activities.
- Manage, coach, and develop the validation team and allocate resources effectively.
- Define and improve validation policies, standards, and procedures.
- Select appropriate validation strategies and methodologies based on risk and compliance needs.
- Represent validation in strategic discussions with senior site leadership.
- Collaborate closely with manufacturing, engineering, quality, and external partners.
- Support change control assessments, deviation investigations, and CAPA activities.
Requirements
- Bachelor\'s or Master\'s degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 8-10 years of experience in validation within a GMP‑regulated environment.
- Proven experience leading validation teams and complex CQV programs.
- Strong knowledge of GMP, GxP, and regulatory expectations (e.g. FDA, EMA).
- Experience applying risk‑based validation and quality risk management.
- Strong leadership, organizational, and decision‑making skills.
- Ability to communicate effectively with stakeholders at all levels.
- Project based contract through Oxford Global Resources till the end of the year
- Estimated salary: €8000 gross per month
- Region: Amsterdam area
- Working hours: Monday to Friday, standard office hours (09:00-17:00)
- Additional benefits: Strong professional development and leadership growth opportunities, and working on innovative therapies with high societal impact.