Director Of Quality Assurance – In Vitro - Excellent Opportunity– Pharmaceutical/biotech Industry!
MRINetwork (Baltimore, Maryland)

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DIRECTOR of QUALITY ASSURANCE – IN VITRO - Excellent Opportunity– Pharmaceutical/Biotech Industry!

 

Seeking a great Pharma opportunity?  Wanting to work in a Great Company?  Do you have Lab Management and Regulatory Experience?

 

SC Novi

Hello!  I am Holly Gunter and I am a technical scientific recruiter.  SC Novi is a premier biotech, automotive, and industrial recruiting firm with several great years of experience in improving the lives of scientists.  We are part of the world’s largest recruiting affiliate network and our office has been consistently recognized as a leading office within this network.  To learn more about our company, please visit our website at http://www.scnovi.com/.  

 

 

Director of Quality Assurance – in vitro Department

 

My client is an international provider of life science products and lab services to the pharmaceutical and biotech industries. They possess expertise in rapid detection, analytical and drug development services, and ADME-Tox in vitro technologies.  They are currently seeking a QA specialist who motivates his/her team to excellence through influence and leadership.  This scientist pays exceptional attention to detail.  This Director must also be a team-oriented individual who can multi-task.  This position reports directly to senior management.  This person will be expected to:

 

Provide leadership and direction for the Quality Systems Dept (QA, QC labs, Document Control, Metrology, and Validation Services) Work with product manufacturing and contract services labs to implement, maintain, and upgrade systems and capabilities to be compliant with current GLP/GMP regulations and guidelines as well as ISO 9000  Provide QA expertise and guidance Interpret FDA and other regulations and guidelines Lead the Quality Control Laboratories by coordinating product release testing, reviewing QC data and releasing products Develop and oversee the QA Auditing Program, including taking responsibility for internal and external audit functions and training QA to provide backup. Implement and maintain the SOP system: participate in the development of SOPs and provide final signature review Establishes and maintains an effective CAPA system for the site Evaluate data trends and provide input toward implementation of appropriate corrective actions Keep senior management informed of developing critical quality issues and then proactively provide solutions to address these issues Serve as initial point of contact regarding regulatory inspections and sponsor audits Auditing: train QA to provide backup, perform internal  Effectively communicate (oral and written) status updates including assessment of audit/inspection reports to management Provide site training and leadership for Validation Projects and Calibration Program Formulate and recommend policies and programs for the validation and qualification of laboratory equipment, instruments and computerized systems through exhibiting a working knowledge of FDA Part 11 guidances Lead the Controlled Drug Substances program for the site Implement and oversee document control function     Interview, hire and train employees in direct areas of responsibility Plan, schedule and coordinate departmental activities

 

Note: This position is located in Maryland

 

Must Have:

BS Chemistry, Biology, related – minimum 10+ years in a regulated industry Demonstrated GLP/GMP and ISO 9000 expertise in biotech/pharma >5 yrs management and leadership experience Project Management and strong organization skills

 

Preferences:

§         HPLC and LC/MS experience

§         Experience with establishing and maintaining ISO certification

 

Compensation:

Dependent upon experience

 

If you are interested and qualified, let’s make it happen!

 

Please email your resume in MS Word format to hgresume@scnovi.com.

Please reference position 40022.

 

Thank you for your consideration and I look forward to speaking with you!

 

Holly Gunter

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