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Director, Global Validation

Company: Thermo Fisher Scientific
Location: Hartford
Posted on: September 21, 2022

Job Description:

As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Discover Impactful Work: The Global Validation Director is responsible for Quality Direction for a standardized global Validation approach encompassing Manufacturing and Packaging within the Pharma Services Group (PSG) of Thermo Fisher Scientific. This role will be responsible for ongoing surveillance of the Validation regulatory compliance environment and providing Quality direction to the creation and update of standardized validation approaches, and ensuring sites implement and align with global standards. Within PSG, this employee will collaborate and support the Global Technical Operations teams and Global Commercial packaging by providing Quality oversight and input to the PSG Validation approaches.A day in the Life: Provide Quality direction to a global matrixed team to deliver the Quality elements for Validation. Coordinate team and workstream activities in accordance with the mission and goals of the organization. Lead and direct activities to support development and standardized implementation of Validations. Ensure goals are met regarding timelines, results, safety, quality, and team performance. Engage with Subject Matter Authorities to ensure Quality requirements are addressed.Keys to Success:To be successful, you would need prior experience in Validations, including meaningful technical knowledge of equipment, process design, process qualification (manufacturing / packaging), as well as in-process testing, data integrity, and continuous process verification. Strong project management, and organizational change skills, and the ability to operate in a global environment with more than 65 sites involved with Validations.Education:

  • Bachelors degree in physical science or engineering is required. A masters degree with an emphasis on physical science, engineering, organizational management, or an MBA is preferred.Experience: 10+ years of increasing responsibility in Quality Assurance as an individual contributor and in Quality Assurance management in a GxP environment preferred. 7+ years confirmed experience with GxP Validations (Manufacturing and Packaging) preferred. Shown experience in Quality systems project management and with GxP Validation implementation with respect to prioritization and staging to achieve operational readiness. Thorough understanding of project management methods and standard methodologies based on demonstration of a shown-track record of project delivery. Ideally have experience with a range of dosage forms including oral solids, steriles, cold-chain packaging, and low-volume custom products.Knowledge, Skills, Abilities: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams). Outstanding leadership and organizational skills Excellent interpersonal and communication skills. Be able to effectively communicate strategy at all levels. Excellent problem-solving ability. Have managerial skills of large and small teams with and without direct authority. Ability to work globally, travel up to 50% of the time, globally and domestically, up to one week at a time, and flexibility with work schedules to accommodate different time zones.Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $42 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 sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 120,000 colleagues delivers an outstanding 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 and Patheon. Thermo Fisher Scientific is an equal opportunity employer. For more information, please visit www.thermofisher.com .Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, Hartford , Director, Global Validation, Executive , Hartford, Connecticut

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