Thermo Fisher Scientific Quality Performance and Compliance Leader in Mount Prospect, Illinois

Job Description

Position Summary: The Quality Performance and Compliance Leader is responsible for driving process improvements and compliance within Fisher Clinical Services’ (FCS’s) processes (Operations, Quality, Client Services and Warehousing) in accordance with FCS Standard Operating Procedures, customer requirements and applicable government regulations. Additionally, this critical position will play a key role in the oversight, administration, and maintenance of the site’s entire Quality Management System. This is a highly visible position with great growth potential.

Key Responsibilities:

  • Lead and Participate in Quality related investigations and process improvements with various departments (i.e. performing analysis, investigation of adverse quality trends, implementation of Global Improvement Projects, etc.).

  • Assures site’s process are in compliance with all applicable government regulations, and FCS Standard Operating Procedures and meet Customer requirements.

  • Assist the QA Director and Manager in a variety of functions and environments (i.e. standing-in during customer/auditor/regulator meetings, backing up critical tasks, reviewing Quality Agreements and Client Requirement Documents, etc.).

  • Partner with and serve as a back-up for the Quality Compliance Officer. Assist in final Compliance review and approval of Quality Incidents.

  • Collect and provide Quality data for generating, tracking, trending and reporting Quality metrics as related to the FCS Business and the client for continuous improvement.

  • Lead local Quality Council meetings and facilitate Annual Management Review with site Leadership, participate in Quality Business Reviews (QBRs), and track action items to completion.

  • Ensure local Quality System is in compliance with CTD Global Policies and Procedures.

  • Assist in communication with Client related to quality issues.

  • Assist and support Quality team members in the roll-out and implementation of Global Projects.

  • Extensively interact with all levels of personnel to resolve quality issues.

  • Serve as a mentor to other members within the Quality organization, providing coaching and feedback, while providing leadership in promoting and enforcing company quality requirements.

  • Assist site in development of Adult Learning Modules based on site needs.

  • Domestic or international travel up to 25% may be required.

Basic Minimum Qualifications (BMQs): The requirements listed below are representative of the knowledge, skill and ability required.

Education/ Experience (BMQ):

  • Bachelor’s degree (B.A./B.S.) from a four-year college or university in Life Sciences (Molecular Biology, Biochemistry, Chemistry) or related field

  • At least five years of experience as a QA/QC/Compliance Professional in a pharmaceutical environment or related field

Ability and/or Skills (BMQ):

  • Experience effectively facilitating cross-functional teams in performing investigations and root cause analysis, leading to the identification of appropriate corrective and preventative actions.

  • Working knowledge of Process Improvement, Quality Management, and/or other process improvement tools i.e. Six Sigma, Five Why’s. Value Stream Mapping, Fish bone, 4 M’s and E.

  • Must possess the solid ability and experience in leading Quality Investigations (define problems, collect data, establish facts, and draw valid conclusions).

  • Must have the ability to write reports, business correspondence, and procedure manuals. Must also have the ability to effectively present concise information and respond to questions from Senior Management, peers and clients.

  • Ability to effectively interact with a diverse range of individuals including external clients and operate and/or project a strong professional image.

  • Demonstrate Clear Strength performance ratings in most Leadership Competencies

  • Detailed and process oriented and capable of making independent decisions and recommendations.

  • Ability to relate and effective train complex subject matter to new and experienced personnel.

  • Strong ability to drive tasks/projects to closure in a timely fashion.

  • Strong leadership skills with an outstanding customer-service oriented background along with clear, concise written and oral communication abilities.

  • Ability to work effectively and accurately in a fast-paced environment.

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.