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.
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