Senior Director of Validation
3 days ago
The Senior Director of Validation will lead the validation team and oversee all validation activities related to equipment, systems, processes, and computerized systems and software within the company. This is a Global role, responsible for validation activities at the Framingham, MA (US) Manufacturing facility and Milton Park, Abingdon (UK) quality control and development facility. This role is critical to ensuring compliance with regulatory standards and maintaining the highest quality in our products.
Responsibilities- Lead and mentor the validation team, fostering a culture of excellence and continuous improvement.
- Develop and implement validation strategies and policies in alignment with regulatory requirements and company goals.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, Quality Control and R&D, to ensure validation activities are integrated into the overall project plans.
- Oversee the planning, execution, and documentation of validation activities for equipment, systems, processes, and computerized systems for all GMP and GxP operations.
- Ensure all validation protocols and reports are compliant with FDA, EMA, and other relevant regulatory guidelines.
- Conduct risk assessments and develop mitigation strategies for validation projects.
- Bachelor's or Master's (preferred) degree in Engineering, Life Sciences, or a related field.
- Minimum of 12+ years of experience in validation within the biotechnology or pharmaceutical industry.
- Excellent knowledge of regulatory requirements, industry standards, and guidance (e.g. 21CFR 210, 211, Part 11, EU Annex 1, EU Annex 15, USP, GAMP, ISO14644, etc.).
- Proven leadership and team management skills.
- Excellent communication and interpersonal skills.
- Detail-oriented with a commitment to quality and compliance.
- Ability to work collaboratively in a fast-paced, dynamic environment.
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response.
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