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Patheon
Sr. Manager, Quality Assurance
Greenville, NC - USA
Posted March 20, 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

This position includes functions such as auditing, investigations, dispositions, laboratory and production oversight, stability oversight, regulatory training, submissions, validation, cGMP computer systems, equipment, processes document and records management, change control management, etc.

 

The purpose of this position is to manage the functions and staff, to assure product, process, and records comply with company specifications, legal agreements, and applicable regulations as a requirement for release to license holder and/or market.

Key Requirements
Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems.

 

  • Manage staff that may perform one or a combination of the following functions: manufacturing oversight, stability oversight, retained samples and incoming material release, audits, record review, final product release, complaints, APR, document/records management, change control, regulatory submissions, validation and/or investigations.

     

  • Ensure quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.

     

  • Comply with all job-related safety and other training requirements in a timely manner.

     

  • Support systems and new product introduction as a technical resource by providing assessment technical expertise, problem solving, and strategies for problem prevention.

     

  • Develop strategies and priorities to assure future success of the Company.

     

  • Conduct risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

     

  • Manage resources by budgeting for and assuring availability of staff to meet business needs.

     

  • Maintain current knowledge of emerging trends and technologies. Serve as a technical resource.

     

  • Ensure staff has performance plans with metrics in place. Reviews are conducted twice a year (mid-year and annually).

     

  • Identify and manage performance/discipline issues. 

     

  • Provide training and/or opportunities for career development of staff.

  • Qualifications
    BS/BA in a scientific or related field plus 7 years of experience in the pharmaceutical industry to include 5 years supervisory experience, OR Associates degree in a scientific or related field plus 8 years of experience in the pharmaceutical industry to include 5 years supervisory experience, OR 9 years relevant pharmaceutical/regulated industry experience required.

    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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