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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

Manager, Operations Compliance

How will you make an impact?

Thermo Fisher Scientific Inc. is currently seeking a highly motivated and experienced individual to join our team as a Manager, Operations Compliance. 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 operations compliance team is responsible for manufacturing compliance, inspection readiness, and CAPA management in accordance with current good manufacturing practices (cGMP) working closely with Quality Assurance to meet and/or exceed customer expectations.

What will you do?

• Provide leadership to team by leading organizational change, developing and empowering staff, cultivating relationships, building effective teams that apply their diverse skills and perspectives to achieve common goals, driving engagement and creating a climate where staff are motivated to do their best.

• Lead operational change control review and implementation of corrective actions ensuring processes are following cGMP requirements.

• Partner with Quality Assurance on the floor and compliance teams to ensure deficiencies within the manufacturing core are addressed real time.

• Communicate and promote a culture of compliance and operational excellence throughout the Manufacturing Teams.

• 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.

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

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

How will you get there:

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 industry experience, preferably in a cGMP environment

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

• Demonstrated 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

• Passion for problem solving and developing others in technical skills in a sophisticated, fast-paced environment.

• Strong interpersonal skills and the ability to connect with and positively influence team members and all levels of the organization.

• Able to develop effective training, coaching, and mentoring programs for problem-solving in both non-operational and operational areas.

• Understand cGMP and other regulatory requirements in the operation of cleanrooms.

• Unquestionable integrity, dedication to safety and quality, and accountable when making sure teams follow regulations and procedures.

• Great communicator, including solid written, oral and presentation-giving skills.

• High ethical standards to support a professional business code of conduct.

• Ability to work in a fast-paced environment under pressure, able to multi-task and is results driven.

• Fluent Business level English

Thermo Fisher Scientific is committed to equal opportunity employment and fostering a diverse and inclusive workforce. We believe that different experiences, backgrounds, and perspectives drive innovation and contribute to our success. We are an EEO/Affirmative Action Employer and do 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.

Thermo Fisher Scientific also offers accessibility services for job seekers with disabilities requiring accommodations during the application process. If you need assistance or an accommodation, please contact us at 1-855-471-2255*.

Apply today to be part of our exceptional team and make a meaningful impact in the world. Join Thermo Fisher Scientific in our mission to enable our customers to make the world healthier, cleaner, and safer. #StartYourStory with us.

Apply now: 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.