Sr Manager, QC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Job Title: Sr. Manager – QC Analytical

Position Location: St. Louis, MO

Number of Direct Reports: 2

Number of Indirect Reports: 35+

Position Summary:

When you’re part of Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world!

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 position ensures that all testing processes and departmental documentation meet Patheon - St. Louis and cGMP regulatory standards. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset, and are passionate about encouraging and developing future talent.

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 collaboration with the aims and direction of the QC Director.

Coordinates, 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 leading a team of Managers (or possibly Managers and Supervisors). Direct management of the individual contributors may occur on a limited basis as well.

Key Responsibilities:

· Hires, develops, and leads professionals within the Analytical department.

· Provides mentoring and opportunities for growth as well as takes required 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 and business 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 needs through highly proficient staff.

· Reviews departmental documentation (e.g., Standard Operating Procedures, STPs, and QBRs). Participates in revisions, providing input, as needed.

· Reports department feedback to Quality Control Director. Report appropriate metrics to ensure timelines and turnaround time are on track

· Work with group leads to set deliverables and ensure adherence to commitments

Minimum Requirements/Qualifications:

Education and Experience:

· Bachelor's Degree Science, Biochemistry or equivalent

· 7-10 years of proven experience in a regulated manufacturing, Quality or QC laboratory environment

· 7+ years prior supervisory or management experience required.

Knowledge, Skills, Abilities:

· Extensive knowledge and exposure to cGMP environment. Experience in general and specific QC testing principles, as applicable to focus of position (e.g., chemistry, biochemistry, bio-assay, etc.). Audit experience.

· Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation including biologic specific methodology.

· Strong interpersonal and communications skills; written and oral.

· Understanding of applicable regulatory requirements as it relates to analytical method transfer, 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 within and outside of department. Collaborate external contacts. Ability to work cross functionally with members of Quality Control, Operations, and Biologics Process Science (BPS) to meet timelines and objectives

Other Job Requirements:

· Adhere to OHS policies and procedures and ensure a safe 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.