GxP Training - Sr. Manager Quality Standards, Training & Improvements (Contract) 25622

The Senior Manager plays a pivotal role in supporting the Associate Director of GxP Quality Training by managing the strategic execution of training initiatives and ensuring alignment with quality goals, regulatory standards, and business objectives. This role requires expertise in instructional design and adult learning principles to create impactful training solutions tailored to diverse learner needs.

The Senior Manager serves as a primary point of contact for designated functional area(s), ensuring training initiatives meet specific business needs while aligning with broader organizational objectives. They will also collaborate closely with an LMS Training Administrator to implement technical logistics and manage LMS-related projects. Through cross-functional collaboration and strategic leadership, the Senior Manager drives consistency, compliance, and innovation in training practices. Additionally, this role requires expertise in GxP processes and responsibilities, GxP Quality Assurance experience, and GxP document control processes to ensure compliance and quality across all training programs.

KEY RESPONSIBILITIES:

• Serve as a dedicated training partner for designated functional area(s), working closely with leaders and teams to identify training needs and implement tailored solutions.
• Act as a liaison between functional areas and the Quality Training team, ensuring alignment of training goals with operational and quality objectives.
• Apply instructional design principles, learning needs analyses, and adult learning methodologies to develop effective, engaging, and GxP-compliant training materials, including eLearning, workshops, and interactive sessions.
• Design training programs that address specific learner needs within designated functional area(s) and align with organizational objectives.
• Oversee large-scale LMS and training documentation-related projects to ensure seamless end-to-end process for GxP training operations.
• Support the Associate Director in implementing the strategic training roadmap by overseeing the development and delivery of training initiatives.
• Collaborate with strategic training partners to ensure consistent and effective application of training practices across the organization.
• Serve as an escalation point for operational challenges, providing solutions to support uninterrupted training operations.
• Collaborate with leadership to troubleshoot and resolve training-related issues effectively.
• Oversee GxP document control processes related to training, ensuring the accuracy, accessibility, and compliance of training materials.
• Support audits and inspections by providing documentation and ensuring adherence to regulatory standards.
• Identify opportunities to enhance training processes, content, and delivery methods by leveraging feedback and data-driven insights.
• Promote a culture of learning and innovation by driving initiatives that improve training impact and efficiency.
• Evaluate training effectiveness using appropriate metrics to ensure learning objectives are met and compliance requirements are achieved.
• Support execution of the global quality training strategy through cross-functional collaboration, process harmonization, and continuous improvement.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Instructional Design, Education, Life Sciences, or a related field. A master’s degree is preferred.
• A minimum of 5 years of experience in GxP training within the pharmaceutical, medical device, or healthcare industries.
• Advanced expertise in project management, instructional design, adult learning principles, GxP Quality Assurance processes, and LMS systems.
• Professional certifications in Learning & Development (e.g., CPLP, APTD) or instructional design tools are a plus.

$75-$80/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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