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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Location: Bethesda MD
  • Source: Business
  • Ad #: 15580
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Kelly Services is currently seeking a DIRECT HIRE Senior Manager of QA Operations (Quality Assurance for an esteemed client located in Houston, TX. This position will oversee 2 – 5 direct reports and is expected to be a leader of all aspects of QA Operations for Clinical / Commercial GMP Viral Cell Therapy and Batch Viral contract manufacturing.

A commercial/manufacturing/clinical mix of skills is desired for this role. Majority work is done in an office environment or in meetings held in a conference room. Some work requires entry into a laboratory setting. Occasional travel is required. Possible weekend and evening coverage may be needed.

This is a DIRCT HIRE opportunity with BENEFITS and FULL RELOCATION ASSISTANCE.

The ideal candidate will have:

  • Working knowledge of cGMP for commercial pharmaceutical manufacturing
  • Knowledge of manufacturing processes typical for biologics and sterile drugs
  • Thorough understanding of regulatory requirements for biologics manufacturing
  • Interpretation and application of US and EU.
  • Any ASQ certification (preferable, but not required)

Responsibilities:

  • Apply detailed knowledge and understanding of aseptic technique, sterile drug product manufacturing and quality assurance operations.
  • Display an ability to apply cGMPs in the manufacturing environment in a compliant and pragmatic manner.
  • Apply a great understanding of validation/qualification principles, industry practices and standards with ability to apply these to GMP operations as a QA reviewer / approver.
  • Working knowledge of all Quality Systems required for a biologics manufacturing facility.
  • Apply a demonstrated ability to lead GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
  • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
  • Able to communicate status, needs, forecasts, risks and timelines effectively to management.

Qualifications:

  • Bachelor of Science; Preferred area of study: Biology.
  • 13+ year’s biopharmaceutical manufacturing experience and/or quality operations or quality system working in a GMP environment.

Apply Today for Immediate Consideration!

 
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