Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Position Summary:

The Director of GxP Learning & Document Management is responsible for leading the strategic development, implementation, and oversight of comprehensive GxP (Good Practice) training programs and documentation management standards across the organization. This role ensures colleagues are trained in GxP standards and that documentation practices align with regulatory requirements.

Establish, deepen, and sustain partnership and subject matter authorities to understand business needs, priorities, and performance gaps. Demonstrate an understanding of drug development processes, knowledge, and skills to provide appropriate learning solutions.Partner and engage with Functional Leaders, Key Stakeholders, and Process Leaders to develop learning plans that align with PSG strategy and goals. Diagnose the organization's capability gaps; and identify, develop, and implement global learning solutions to build critical capabilities for the business.Using data to continuously develop and deliver a learning portfolio; and set data metrics required to measure business value; and drive continuous process.

Key Responsibilities:

Oversee and enhance our documentation management system. Develop, implement, and maintain a simplified and robust system for efficient and secure handling of all organizational documents. Responsibilities include assessing current processes, identifying improvements, standardizing procedures, ensuring regulatory compliance, and managing document storage, retrieval, and archiving. Collaborate with departments to understand their needs, promote best practices, and optimize document workflows.Oversee the creation, review, and approval of all critical documentation, including SOPs, work instructions, training materials and conduct regular audits. Stay informed about industry trends and regulatory changes.Design, implement and continuously improve GxP training and certification programs that enhance and achieve exceptional results and maintain high standards of excellence in employee skills, knowledge and work. Ensure training programs meet the needs of various departments, and continuously evaluate and incorporate innovative training methods and technologies.Assess, measure and analyze the impact of the training programs on employee performance and organizational goals. Develop and manage training budgets, ensuring cost-effective delivery of training programs. Establish and maintain documentation standards and procedures to ensure accuracy, consistency, compliance and efficiency

How will you get there?

Education

Bachelor’s degree in a related field; Master’s degree preferred.

Experience

Proven experience in GxP training and documentation management, preferably in a regulated industry; and a strong understanding of regulatory requirements.

Competencies

Strong attention to detail, effective time management and while thriving in a fast-paced, dynamic environment while balancing multiple priorities.

Excellent communication and project management skills.

Ability to think strategically and problem-solve; and the ability to work collaboratively across departments and with global teams.

Some travel is required.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!