Director of Quality and Compliance

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Our Client is seeking a Director of Quality & Compliance for their Central Virginia location.  They are a privately held global Pharmaceutical Company in the business of sustaining and improving the quality of life for the customers of their products. They are seeking a person that will provide leadership and direction for implementing quality polices systems and procedures that will ensure full company compliance.  Specific functional areas include material control, quality systems, compliance, regulatory affairs and company wide site validation.

REQUIREMENTS:

·  The successful candidate must have a PhD in Chemistry, Chemical Engineering or related discipline.

·  A minimum of 10 years experience managing or implementing quality systems and processes in the pharmaceutical industry and

·  A thorough working knowledge of cGMP, DEA regulations, FDA regulations and Q7A is required. 

DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:

·  Participates in the establishment of quality systems, regulatory affairs/compliance procedures to ensure company wide compliance with all regulatory agencies (for example: FDA, DEA and EMEA.

·  Ensures the timely submittals of all regulatory submissions and documentation including batch records, DMF’s and other necessary documentation. 

·  Oversees and serves as liaison for all regulatory and customer audits. Also serves as the company representative for all quality and regulatory activities both on an internal and external level.

·  Provides leadership in the area of controlled substance compliance by designing, implementing and improving effective strategies. 

·  Evaluates, analyzes, and reports to management the status of the quality system and compliance, proposes corrective action plans where appropriate, and recommends disposition of non-conforming materials.

·  Oversees the training of employees to required regulations.

·  Maintains a safe work environment and ensures that employees in area of responsibility are properly trained and follow safety procedures.

The Company offers competitive compensation and a comprehensive benefits package. If you are qualified for this position and would like to be considered, please submit your resume along with a cover letter as Microsoft word documents via email to Tom Askew at taskew@rrsearch.com