Manager, Validation
About The Position
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Job Summary We are seeking a Manager, Validation to lead and oversee validation activities and Validation Quality Systems for site‑level GMP systems. This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements. The Manager, Validation supports timely completion of validation documentation, drives continuous improvement initiatives, and serves as a subject matter expert for validation and electronic data integrity. This role partners closely with Manufacturing, Engineering, IT, Quality, and external vendors, and plays a key role in supporting regulatory inspections. The position also provides leadership, coaching, and development for members of the Validation team. About Our Validation Team You’ll join a dedicated Validation Team responsible for ensuring GMP systems are fit for intended use, compliant, and inspection‑ready. The team works cross‑functionally with operational and technical partners to support a growing and increasingly complex environment. Our approach emphasizes risk‑based validation, strong technical knowledge, and continuous improvement. The environment is fast‑paced, highly collaborative, and focused on delivering compliant, business‑ready solutions.
Requirements
- Bachelor’s degree (BS/BA) with 8+ years of relevant industry experience, or Master’s degree with 6+ years of relevant experience. Equivalent education and experience may be considered.
- Demonstrated experience in GMP validation within a regulated pharmaceutical or life sciences environment.
- In‑depth knowledge of global regulatory expectations related to validation, computerized systems, and electronic records.
- Demonstrated subject matter expertise in validation and IT systems compliance as defined by pharmaceutical regulatory authorities.
- Hands‑on experience with cloud-based and service-based system validation and Computer Software Assurance (CSA), including systems such as ERP, LIMS, and QMS.
- Ability to work flexible hours as needed to support network and operational requirements.
Nice To Haves
- Strong facilitation and project management skills with the ability to manage multiple priorities.
- Excellent written and verbal communication skills.
- Strategic understanding of validation lifecycle activities and electronic record/data integrity requirements.
- Exceptional stakeholder and customer interface skills.
- Proven ability to lead, coach, and develop validation professionals.
Responsibilities
- Lead and support the completion of GMP validation documentation for site systems, ensuring milestones and deliverables are met on agreed timelines.
- Oversee the implementation and maintenance of Validation Quality Systems, including policies, procedures, guidance documents, training, and tools.
- Monitor and maintain controls, procedures, and guidance that define and align validation activities for both internal and external GMP systems.
- Drive continuous improvement initiatives to enhance efficiency, effectiveness, and consistency of validation operations.
- Serve as a subject matter expert for validation practices and electronic data integrity requirements.
- Partner with cross‑functional stakeholders including IT, Engineering, Manufacturing, Quality, and external vendors to support validation activities.
- Support regulatory inspections and audits related to validation and computerized systems.
- Provide coaching, performance feedback, and professional development to Validation team members.
- Ensure validation strategies and execution align with FDA, EMA, and other global health authority expectations.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
