Jobs for Veterans, Veteran Job Board | GiJobs.com

Post Jobs

Job Information

Thermo Fisher Scientific Quality Compliance Supervisor in Florence, South Carolina

Job Description

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 real-world impact, and you’ll be supported in achieving your career goals.

How you will make an impact

The Quality Compliance Supervisor will provide leadership and guidance to a team of Quality Assurance Compliance Leads who will act as a direct liaison between clients and the site’s quality unit to ensure adherence to the expectation of the client are being met and facilitating projects through the site’s Quality Systems. This team is critical to maintaining the site’s right-to-operate in support of producing and releasing quality bulk drug substances for clinical and commercial clients. This role will interface closely with other internal cross-functional groups such as Operations, Maintenance, Engineering, R&D, Business Management and Quality as well as external clients.

What you will do

  • Function as a member of the site’s Quality Assurance Leadership team to maintain the site’s quality right to operate, and a constant state of inspection readiness.

  • Directly responsible for the oversight of the site’s inspection programs to ensure the site maintains a state of inspection readiness.

  • Directly responsible for leading, developing, and mentoring a team of Quality Compliance Leads to stay abreast of current industry practices and client expectations.

  • Directly responsible for ensuring Quality participation on cross-functional project team to provide open communication to clients on quality related issues and site standards associated with their project.

  • Directly responsible for ensuring Product Quality Lead will lead and / or support thorough investigations of client-related quality issues (CAPA’s, Discrepancies, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.

  • Directly responsible for ensuring Quality participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects to enhance client satisfaction.

  • Directly responsible for ensuring client notifications and approvals are performed as defined in product’s Quality Agreement.

  • Directly responsible for ensuring Quality oversight of client product related topics including but not limited to deviations, change controls, batch record reviews, batch release, and specification management.

  • Directly responsible for ensuring Quality oversight of client product validation and pharmacovigilance programs (as applicable).

  • Directly responsible for ensuring the development of client product related Annual Product reviews (as applicable).

  • Directly responsible for ensuring regular status updates are provided on client’s quality expectations to local Quality Assurance team.

  • Interface with clients by assisting with addressing their questions and concerns as they relate site strategy for controlling product quality through quality systems.

  • Participate in audits and inspections performed by clients.

  • Participate in inspections by regulatory agencies.

How you will get here

Education

  • Bachelor’s Degree in Technical or Science related field.

Experience

  • Minimum of 5 years of cGMP experience in a QA/QC leadership role, preferably with a plant manufacturing focus.

  • Knowledge of 21 CFR 210, 21 CFR 211, ICH Q7 and other regulatory standards governing the manufacture of bulk drug substance.

  • Experience with integration Quality Risk Management principles into Quality System elements.

  • Experience in investigational writing software system is a plus (TrackWise) along with root cause analysis tools utilized in deviation investigations

  • Tech transfer experience is a plus

Knowledge, Skills, Abilities

  • Demonstrated ability to work effectively with individuals at all levels of the organization (including internal and external customers).

  • Demonstrated ability to make quality decisions is required.

  • Demonstrated history of building teams and interdepartmental relationships

  • Understanding of risk management principles and ability to apply these principles in day to day Quality Management activities, quality and compliance issues and business challenges.

  • Critical thinking with the ability to read, analyze, and interpret technical data

  • Excellent oral and written interpersonal communication skills

  • Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)

  • Must be able to read, write, and communicate in English

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.

DirectEmployers