Senior Manager, R&D Training (GxP)

Senior Manager, R&D Training (GxP) - Perm - Cambridge, Massachusettes

Proclinical is seeking a Senior Manager, R&D Training (GxP) to co-manage a global GxP Training Program at a well known biotech company. This hybrid role involves both on-site work in Cambridge, MA, and remote work.

Primary Responsibilities:

The successful candidate will focus on maintaining a compliant GxP Training Program, managing a validated electronic learning management system, and delivering quality/regulatory compliance training.

Skills & Requirements:

• Bachelor's Degree or higher in a scientific discipline preferred.
• Expertise in GCP regulations and ICH E6(R2); additional GCLP/GLP/GVP/GRP experience a plus.
• Experience designing and delivering GxP training and creating eLearning materials.
• Proficiency with electronic Training Learning Management Systems, preferably Veeva Training Vault.
• Strong computer skills, particularly with MS Office Products.
• Ability to identify continuous improvement opportunities and drive innovation.
• Strong team player with a track record of success in cross-functional teams.
• Ability to work independently with minimal oversight.
• Excellent communication, presentation, and adult learning skills.
• Strong organizational, computing, and oral/written communication skills.
• Ability to influence and negotiate effective solutions.
• Strong critical thinking and decision-making skills.

The Senior Manager, R&D Training (GxP)'s responsibilities will be:

• Maintain a compliant GxP Training Program in line with US and International guidelines.
• Manage and validate the electronic learning management system (Veeva Training Vault).
• Own and update training SOPs and materials.
• Design and deliver quality/regulatory compliance training.
• Collaborate with functional areas to identify training roles and curricula assignments.
• Serve as the primary contact for GCP, GCLP, GVP, and GRP training needs.
• Ensure compliance with global regulations and internal training policies.
• Manage training matrices, role-based training, and curriculum requirements.
• Design and deliver various training formats, including CBT courses and microlearning videos.
• Align training operations with R&D and Technical Operations organizations.
• Support the GLP training team at the Gene Therapy Center of Excellence.
• Conduct annual curricula reviews and manage new hire QMS training.
• Utilize and support the Veeva Training Vault LMS.
• Perform periodic assessments and escalate issues as needed.
• Verify KPI results and drive on-time training completion.
• Provide cross-functional support and participate in company initiatives.

Compensation:

• USD 165 000.00 - 170 000.00 per annum

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.