Sr. Manager, Quality Training

4DMT is hiring a Sr. Manager, Quality Training to manage 4DMT's Quality Training Program. The Sr. Manager, Quality Training will be responsible for driving user-focused strategies to ensure effective and compliant training is efficiently delivered enterprise-wide via 4DMT's Learning Management System.

The Sr. Manager, Quality Training will be responsible for working with key stakeholders in the business to define training requirements and ensure 4DMT's training processes and LMS configuration are designed to optimally achieve these requirements. This role is also responsible for ensuring training program inspection readiness / inspection support, maintenance of training records, and coordination of periodic in-person GXP training activities.

Reporting to the Sr. Director of QA and Compliance. This role can be in-person or hybrid.

RESPONSIBILITIES:

• Management of 4DMT's Quality Training Program = 100% of the time:

• Define/update policies and procedures related to 4DMT's Quality Training Program

• Work with functional leaders across the business to ensure enterprise-wide, role-based training requirements are defined appropriately and implemented within the LMS

• Provide direction/guidance on Learning Management System configuration and related processes to IT LMS system administrators

• Ensure LMS is configured and administered effectively to manage course deployments, tracking, and reporting

• Ensure LMS course assignments are accurate and appropriate through governance and partnerships with functions across 4DMT

• Author, coordinate, and execute regularly scheduled GxP / quality onboarding training for new hires

• Coordinate annual GMP and GCP refresher training for personnel supporting GMP and GCP activities respectively

• Participate in cross-functional project teams to refine training and on-boarding processes

• Manage training administration, communications, curricula endorsements, and reporting

• Ensure consistent implementation of LMS assessment feature best practices and standards

• Work with assigned areas/lines to plan and coordinate training sessions to support compliance

• Ensure that compliance reporting and inspection readiness support is provided to customers

• Track and support reporting of training compliance metrics

• Manage archival of training records as needed

• Support audits/inspections of the training program and serve as the training program Subject Matter Expert during regulatory inspections

• Work with interdepartmental subject matter experts at all levels of the organization to plan, develop, and coordinate execution of GXP training programs / initiatives

QUALIFICATIONS:

Education:

• B.Sc. minimum

Experience:

• 5 - 8 years of experience in biotech / pharmaceutical industry, including a training-related role.

• Demonstrated knowledge of adult learning principles, instructional design, and project management expertise.

• Advanced business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry.

• Demonstrated ability to manage multiple, highly complex projects concurrently.

• Prior experience in monitoring adherence to compliance-based training programs.

• Demonstrated ability to influence and negotiate effectively and implement large-scale change.

• Experience with Learning Management Systems (experience with ComplianceWire preferred)

Skills:

• Knowledge of LMS administration and processing

• Excellent written and verbal communication skills

• Strong organizational skills

• Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint,), Adobe Acrobat, survey tools.

• Knowledge of GCPs, GLPs and GMPs

Base salary compensation range is $132,000 - $155,000

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience