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Patheon
Manager, Quality Control (Sample Mgmt & Operations)
St. Louis, MO - USA
Posted April 18, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

Responsible for overseeing, managing, and ensuring day-to-day QC Operations, including management and scheduling of all types of samples/testing: routine operations, stability, method qualification, validation. Works with lab to ensure materials / samples are available and ready to successfully perform necessary testing in accordance with required timelines.

REPORTING RELATIONSHIPS: Typically manages 3 - 6 direct employees
Key Requirements

Responsible for overseeing, managing, and ensuring the successful day-to-day QC Operations, including management and scheduling of all types of samples/testing: routine operations, stability, method qualification, validation. Works with lab to ensure materials / samples are available and ready to successfully perform necessary testing in accordance with required timelines.

Manages professionals within Quality Control. Hires and develops employees within the Quality Control department. Provides feedback and coaching, provides opportunities for growth and takes necessary disciplinary actions. Ensures awareness and compliance with Health authority regulations

Coordinates/drives special projects within functional area and assigns resources as appropriate. Interfaces with customers to ensure clear and open communication is maintained. Responsible for the capacity forecast model for human and equipment resources and represent the QC organization at site / BU planning meetings

Work with QC Director and Quality Leadership to continually seek ways to improve the Quality Culture of the organization and specifically of QC. Approves department budget and initiates cost control measures.

Ensures adequate training (skills-based, cGMP and Safety) of analysts within department, to support commercial production and Pharmaceutical Development 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 Director. Approves department budget and initiates cost control measures


Qualifications

EDUCATION AND QUALIFICATIONS:

  • Bachelor’s Degree in Life Sciences
  • 7-10 years of experience in a regulated manufacturing or QC laboratory environment
  • 2 years prior supervisory or management experience required.
  • Extensive exposure to cGMP environment. Audit experience.
  • Extensive knowledge of general and specific QC testing principles, as applicable to focus of position (e.g., raw materials, chemistry, microbiology, etc.).
  • Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation.
  • Strong interpersonal and communications skills; written and oral.
  • Solid understanding of applicable regulatory requirements.
  • Significant laboratory documentation review and revision experience.

POSITION REQUIREMENTS:

  • 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.
  • Provides overall departmental feedback to senior management.
  • Delegates and/or participates in Health Agency/internal audits.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee is:

  • Able to aseptically gown and/or sterile gown as needed
  • Able to work within environmental clean rooms
  • Able to function in a rapidly changing environment and balance multiple priorities simultaneously
  • Required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  • Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.


Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 
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