Associate Director, Quality Standards, Training, & Improvements (Remote)

Job Description

The Associate Director of Quality Stands, Training, & Improvements, is responsible for leading strategic training initiatives and ensuring consistency, alignment, and evolution of training practices across Vertex Pharmaceuticals. This individual acts as a team lead for strategic training partners, supporting the design, implementation, and continuous improvement of training programs that meet regulatory requirements and Vertex’s quality standards. In collaboration with the Director and other Associate Directors, the Associate Director serves as an issue escalation point of contact for the training team, helping to troubleshoot challenges, forecast business needs, and prioritize training-related initiatives. This role also involves engaging with leadership and stakeholders to understand, troubleshoot, and manage operational business needs. Additionally, this role requires expertise in GxP process ownership and responsibilities, GxP Quality Assurance experience, and GxP document control processes to ensure compliance and quality across all training programs

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Act as a team lead for strategic training partners, providing guidance, alignment, and support to ensure the consistent application of training practices.
• Facilitate the evolution of best practices for training development and delivery across the organization.
• Serve as an escalation point of contact for the training team, addressing issues and providing solutions to support effective training operations.
• Collaborate with stakeholders to resolve quality and compliance challenges related to training programs.
• Help forecast and prioritize business needs involving training, ensuring alignment with strategic and operational goals.
• Work with leadership and stakeholders to identify future training requirements and allocate resources effectively.
• Collaborate with the Director and Associate Directors to design, execute, and refine the strategic roadmap for GxP training and personnel qualification systems.
• Contribute to the integration of innovative learning methodologies and technologies to enhance training impact and scalability.
• Ensure training programs are aligned with regulatory requirements, industry standards, and Vertex policies.
• Support oversight for the Learning Management System (LMS), ensuring it is optimized to meet organizational needs
• Leverage knowledge of GxP processes and responsibilities to ensure training aligns with regulatory and quality assurance standards.
• Oversee and ensure compliance with GxP document control processes, maintaining high standards of accuracy, integrity, and accessibility of training-related documentation.
• Partner with internal stakeholders and external vendors to ensure training programs support organizational goals and compliance requirements.
• Foster collaboration across departments to align training initiatives with business objectives.
• Drive improvements in training processes and practices, leveraging feedback and data-driven insights to enhance outcomes.
• Promote a culture of learning and quality by championing continuous improvement initiatives.
• Lead the creation and delivery of eLearning courses, workshops, and other training formats.
• Evaluate the effectiveness of training programs using metrics and feedback to ensure requirements are met and programs remain impactful.
• Maintain adherence to GxP regulations and quality standards, ensuring all training programs are audit-ready.
• Apply GxP Quality Assurance expertise to ensure training programs effectively address compliance requirements and quality risks.

Minimum qualifications:

• Master’s degree in Business, Psychology, Education or a related field and a minimum of 6 years of relevant experience in GxP training within the pharmaceutical, medical device, or healthcare industries.
• Experience in GxP process ownership and responsibilities, GxP Quality Assurance, and GxP document control processes is required.
• Professional certification (e.g., Certified Professional in Learning and Performance) is a plus.

In-depth knowledge in the following areas:

• Strategic Leadership: Demonstrated ability to lead strategic training partners, ensuring alignment and fostering the evolution of training practices.
• GxP Expertise: Deep understanding of GxP processes, quality assurance requirements, and document control practices to ensure compliance and quality.
• Collaboration and Escalation: Skilled in serving as an escalation point of contact, with the ability to troubleshoot is