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Associate Director Quality Assurance (OTC)

Omega Management Group

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Location: NW Atlanta, GA Posted Date: 4/15/2013 Position Type: Full time Job Code: 4267 Required Education: Bachelors Degree

Description

Associate Director, Quality Assurance
Objective:
Plans, organizes and manages the Quality Assurance systems for contract manufactured products. Manages the clinical quality assurance functions for products under development and/or commercial distribution.  Supports compliance functions to ensure compliance to internal quality standards and regulations.
Major Responsibilities:
The major responsibilities (60% of the time dedicated to these activities)
•   Support Clinical Quality Assurance program conducting GCP audits as required and provide quality guidance as needed.
•   Support other compliance areas in the company as it relates to Quality Assurance tasks as needed.
•   Conduct internal audits as it relates to quality and compliance.
•   Conduct GMP audits of suppliers and contract firms as needed. These may include due diligence and for cause audits.
•   Provide technical and quality support to the plant quality and manufacturing organizations.
•   The incumbent will have direct responsibility for day to day liaison with contract manufacturers to assure continuity in the supply of procured products.  As necessary, visits to contractors to assure ongoing adequacy of quality systems and processes.
•   Assures, through review of submitted documentation, that procured products conform to cGMP requirements and other requirements relating to quality as defined in Supplier & Quality agreements.
•   Provides ongoing administration of the nonconforming materials control system and activities for contract supplied products and services to include the establishment and maintenance of Corrective Action and Preventive Actions (CAPA).
•   Keeps Supply Chain Management (SCM) and other functions informed as to the status of procured products.
•   Develops and negotiates Quality Agreements as needed.
•   Assures that systems and processes developed for contract manufacturers are rationally designed and carried out so as to provide assurance that product and services are procured at or below planned cost. This includes but is not limited to the development and execution of Technology Transfer Protocols, Validation (Process, Method and Software).
•   The incumbent shall have primary responsibility for timely Annual Product Reviews (APR’s) for procured products. As well as periodic reviews of the contractors systems and processes.
Other support activities (40% of the time dedicated to these activities)
•   Contract manufactured batch record reviews
•   Generate Change Controls in support of externally manufactured products and circulate for review and approval within the company to ensure compliance with product regulatory filings.
•   Audit of Speaker Programs in support of Corporate Compliance initiative.
•   Develop, review and approve internal policies and procedures.
•   Coordinate USP/NF reviews with manufacturing facility and with contract manufacturers to ensure compliance.
•   Review and approve complaint investigation from contract manufacturers.

Requirements

Minimum Requirements:
BS in Biology, Chemistry, Physical Science, Engineering or Pharmacy is required.  Advance degree in a scientific or business area preferred.
Experience/Skills:
•   10+ years industry experience and 3+ years auditing experience in a regulatory compliance environment.
•   Must be willing to travel worldwide approximately 25-30%.
•   Must have a thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of findings of internal/external audits.
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