Senior QC Manager

Job Description

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 mission-enabling our customers to make the world healthier, cleaner and safer.

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.

Job Title: Sr. Manager - QC Analytical

Position Location: St. Louis, MO

Number of Direct Reports: 2

Position Summary:

This position is responsible for managing and coordinating the safety, quality, execution, and continuous improvement activities of the Quality Control Analytical (Bioassay, Biochemistry and HPLC) departments. This includes sampling, testing, and inspecting products, facility samples, and raw materials to ensure compliance with quality standards and production schedules. This position ensures that all testing processes and departmental documentation meet Patheon - St. Louis and cGMP regulatory standards.

As a leader for the site, this individual will exhibit leadership traits and characteristics and be perceived by not only their group as a leader, but also by the site when Quality Control issues arise around the site. This will be accomplished by ensuring the following responsibilities are met, and by ensuring a strong Quality culture is maintained throughout the QC portions of the facility in cooperation with the aims and direction of the QC Director.

Oversees, manages, and ensures the successful day-to-day operations of Quality Control departments for the company. The Sr. Manager ensures this success of the teams by oversight of the Managers (or possibly Managers and Supervisors) of the functional groups. Direct management of the individual contributors may occur on a limited basis as well.

Key Responsibilities:

• Hires, develops, and manages professionals within the Analytical Services department.
• Provides feedback and coaching, provides opportunities for growth and takes necessary disciplinary actions.
• Ensures awareness and compliance with Health authority regulations
• Coordinate/drive customer specific projects within functional area and assigns resources as appropriate. Works with customers to ensure clear and open communication is maintained.
• Responsible for the capacity forecast model for human and equipment resources and represents the Analytical Services organization at site / BU planning meetings
• Work with Quality Control Director and Quality Leadership to continually seek ways to improve the Quality Culture of the organization and specifically of the Analytical Services Department.
• Approves department budget and initiates cost control measures.
• Ensures adequate training (skills-based, cGMP and Safety) of personnel within department, to support various phases of production both clinical and commercial and Biologics Process Sciences Staff needs through highly competent staff.
• Reviews departmental documentation (e.g., Standard Operating Procedures, STPs, and QBRs). Participates in revisions, providing input, as necessary.
• Provides overall departmental feedback to Quality Control Director.
• Report appropriate metrics to ensure timelines and turnaround time are on track
• Work with group leads to set milestone deliveries and ensure adherence to commitments

Minimum Requirements/Qualifications:

Education and Experience:

• Bachelor's degree or equivalent
• 7-10 years of experience in a regulated manufacturing, Quality or QC laboratory environment
• 5 years prior supervisory or management experience required.

Knowledge, Skills, Abilities:

• Extensive knowledge and exposure to cGMP environment. Audit experience.
• Extensive knowledge of general and specific QC testing principles, as applicable to focus of position (e.g., chemistry, biochemistry, bio-assay, etc.).
• Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation including biologic specific methodology.
• Strong interpersonal and communications skills; written and oral.
• Solid understanding of applicable regulatory requirements as it relates to analytical method transfer, microbiological verification, USP, and stability
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA
• Oversight of complex functional department, often including junior management levels
• Communicate effectively to peers and all levels of the organization within and outside of department. Interact with external contacts.
• Ability to work cross functionally with members of Quality Control, Operations, and Biologics Process Science (BPS) to meet timelines and objectives in a compliant manner
• Delegates and/or participates in Health Agency/internal audits.
• Provides overall departmental feedback to senior management.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

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.