Senior Manager Quality Operations

Thermo Fisher Scientific   •  

Greenville, NC

Industry: Professional, Scientific & Technical Services

  •  

8 - 10 years

Posted 47 days ago

Job Description

When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.


Job Summary

Performs audits, investigates, dispositions, laboratory and production oversight, stability oversight, regulatory

training, submissions, validation, Current Good Manufacturing Practices (cGMP) computer systems, equipment,

processes document and records management, change control management, etc. Manages the functions and staff,

to assure product, process, and records comply with company specifications, legal agreements, and applicable

regulations as a requirement for release to license holder and/or market.

Responsibilities

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. Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance

requirements, establishing, and maintaining systems.

3. Manages staff that may perform one or a combination of the following functions: manufacturing oversight,

stability oversight, retained samples and incoming material release, audits, record review, final product

release, complaints, APR, document/records management, change control, regulatory submissions, validation

and/or investigations.

4. Ensures quality of methods, processes, materials and products by providing coordination and review of group

operations, staff training, and the assessment/improvement of systems and processes.

5. Complies with all job-related safety and other training requirements in a timely manner.

6. Supports systems and new product introduction as a technical resource by providing assessment technical

expertise, problem solving, and strategies for problem prevention.

7. Develops strategies and priorities to assure future success of the Company.

8. Conducts risk assessments and take appropriate actions during quality system management and oversight

activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality,

safety and business risks.

9. Manages resources by budgeting for and assuring availability of staff to meet business needs.

10. Maintains current knowledge of emerging trends and technologies. Serves as a technical resource.

11. Ensures staff has performance plans with metrics in place. Reviews are conducted twice a year (mid-year

and annually).

12. Identifies and manages performance/discipline issues.

13. Provides training and/or opportunities for career development of staff.

Job Scope:

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

short-term goals of the company.

Preferred Qualifications

Bachelor’s degree in a scientific or related field

Seven years of experience in the pharmaceutical industry that includes five years supervisory experience

Equivalent combinations of education, training, and relevant work experience may be considered.

Physical Requirements

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations;

ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry,

move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and

type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and

read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for

prolonged periods of time.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job.

The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required

skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully

comply with all obligations imposed by the legislation of each country in which it operates, including the

implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

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.




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.