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Thermo Fisher Scientific Sr. Manager, QA in Greenville, North Carolina

Job Description

Sr Manager, QA

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you’ll be supported in achieving your career goals.

Division

Pharmaceutical Service Group

What you will do

Provide quality oversight to the Steriles Pharmaceutical Development Services (PDS) manufacturing operations ensuring the continuation of the site’s license to operate from a Current Good Manufacturing Practices (cGMP) compliance standpoint and to ensure no harm is done to patients due to errors and deviations of manufacturing activities. In addition, provide quality oversight and assist with new technologies/models such as condo, syringes, etc. Ensures best-in-industry as it relates to continuous improvement by increasing quality, compliance and efficiency standards.

What you will do

  1. Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; 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.

  2. Sets strategy and direction to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way.

  3. Represents Manufacturing Quality Assurance in all Regulatory Inspections and Customer Audits.

  4. Ensures efficient operations to support site commitments to customers regarding product delivery and project deliverables.

  5. Provides responsive service to internal and external customers for Manufacturing Quality Assurance.

  6. Represents Manufacturing Quality Assurance on the Quality Management Review committee, as needed. Represents Manufacturing Quality Assurance in quality and compliance issues. Develops and maintains professional relationships with all stakeholders.

  7. Ensures adherence of Operations to all relevant worldwide regulatory requirements. Provides systems to maintain compliance with these requirements.

  8. Remains current in relevant worldwide regulations pertaining to Manufacturing Quality Assurance.

How you will get here

Education:

Bachelor’s degree in Chemical, Biological or related science is required.

Experience:

Seven years of managerial experience in the pharmaceutical industry and at least three years of steriles pharmaceutical experience in Managerial QA is preferred. Steriles clinical experience is also preferred.

Knowledge, Skills, and Abilities

  1. Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and

maintaining schedules. Erroneous decisions or failure to achieve results will add to costs and may impact the goals of the

company.

  1. Advises Quality top management on issues that may affect Steriles PDS as a whole.

  2. Manages and Develops staff in order to realize Safety, Quality, and business goals.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! 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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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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