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.