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ThermoFisher Scientific Manager, Deviation Management in St. Louis, Missouri

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Thermo Fisher Scientific Inc. is currently seeking a highly motivated and experienced individual to join our team as a Manager, Deviation Management and Root Cause Analysis. This is an exceptional opportunity to be part of a world-class manufacturing organization located in St. Louis, MO, USA.

The site is a biologics manufacturing site implementing mammalian cell culture and protein purification processes to support clinical and commercial processing. The deviation management team is responsible for investigating deviations ensuring quality records are processed through to closure in a timely manner working closely with Quality Assurance to handle customer expectations. It is focused on driving quality excellence, prevention of error and deviations, continuous improvement, and effective problem-solving.

Responsibilities:

  • Lead a team of professionals to ensure timely and flawless execution of deviation management processes

  • Responsible for facilitating and performing sophisticated RCA to address complicated problems, training and coaching team members to develop RCA skills within the team and across the site and providing guidance for effective problem-solving including support for conducting effective deviation investigations.

  • Collaborate with cross-functional teams to successfully implement deviation management strategies

  • Compete in a fast-paced environment to meet strict deadlines and deliver high-quality results

  • Define resource needs (capital, expense, and headcount) so that current and future development needs are met. Recruits, hires, retains, trains, and motivates a scientifically competent staff. Provides opportunities for staff career development.

  • Align with all job-related safety and other training requirements including maintaining current training.

  • Live the Thermo Fisher Scientific 4Is values every day. Be proactive.

Education

  • Bachelor’s degree in engineering, science, operations, or business, with evidence of operational, leadership, or professional experience. Master’s degree preferred.

Experience

  • 3+ years of pharmaceutical experience, preferably in a cGMP environment

  • 1+ years of successful management (leadership and talent development) experience with successful track record for developing, training, and coaching teams.

  • Shown success in driving quality systems and leading change with continuous improvement and a dedication to craftsmanship and putting quality first.

  • Technical, engineering, or operational experience in Pharmaceutical Manufacturing and Packaging is preferred.

Knowledge, Skills, Abilities

  • Proven track record in managing and resolving deviations in a manufacturing setting

  • Ambitious and motivated individual with a strong emphasis on continually improving performance

  • Strong leadership and communication skills to effectively collaborate with teams

  • Ability to analyze data and make data-driven decisions

  • Fluent Business level English

At Thermo Fisher Scientific Inc., we are committed to fostering an inclusive and diverse workplace. We value individuals from all backgrounds, experiences, and perspectives, and believe that diversity drives innovation. We are an equal opportunity employer and strictly adhere to a policy of non-discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Thermo Fisher Scientific Inc. also provides reasonable accommodations for job seekers with disabilities. If you require any accommodations during the application process, please contact us at 1-855-471-2255* to discuss your specific needs.

Join our team and start your story with Thermo Fisher Scientific! Apply today at http://jobs.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.

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