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Senior Manager/Associate Director, QA Disposition

Reference Number: 2900
Location: East Coast

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for a Senior Manager/Associate Director, QA Disposition.

This position can be filled at the Senior Manager or Associate Director level depending upon experience.

The Senior Manager/Associate Director, QA Disposition is responsible for assuring the quality of licensed and development-stage products.  This position provides leadership and guidance to a number of functional areas including manufacturing, facilities, and other quality departments, and may support manufacturing operations at contract facilities.  The incumbent will interpret and implement quality policies, manage quality systems, and assist in facilitating regulatory compliance inspections.  This role supervises Quality Assurance Associates and Specialists at the Manufacturing Center.

Major tasks and responsibilities will include:

  • Responsibility for Product Disposition decisions for Clinical and Commercial product as well as Raw Materials.
  • Supervises the QA staff that supports the product disposition.
  • Manages hiring, performance reviews, and employee development plans.
  • Maintains oversight of daily operations within the manufacturing and facilities departments.
  • Maintains QA Systems in a state of compliance with current good manufacturing practice regulations.
  • Supports the Change Request and Nonconformance systems for products manufactured, as well as the associated utilities, process equipment, and facility.  Performs initial regulatory impact assessments, and applies good judgment in consulting with Regulatory Affairs when changes may result in notifiable events.
  • Releases bulk intermediates for shipping to contract fillers.  Assists in the development of specifications for bulk intermediates.  Works closely with Materials Management, Quality Control, and Production departments to assure a continuous supply of product to customers.
  • Investigates, assesses the impact of, and resolves minor, major and critical Nonconformances that may occur during manufacture, testing, or distribution of products, or during the administration of quality systems.  Identifies root causes, recommends and implements corrective and preventative actions.
  • Participates as a technical expert in audits of quality and manufacturing operations.
  • Identifies areas of potential risk and assists the management team in developing and implementing plans to address them.  Alerts management to associated liability issues.
  • Designs metrics to track the performance of operations and quality systems.  Performs trend analysis to monitor process and facility performance.
  • Provides leadership to the QA staff in the areas of personnel development; compliant documentation and record review; evaluation of Nonconformances and Change Requests.
  • Represents the QA department on cross-functional teams, ensuring that department concerns are effectively communicated.
  • Assists in development of departmental budgets.  Participates in the forecasting process, and assessment of headcount requirements.
  • Supervises and trains Quality Assurance Specialists.  Supports the training and development of specialists across all areas of operation at the Manufacturing Center.

We seek candidates with the following qualifications:

  • For Senior Manager: Bachelor’s degree with 7-10 years of experience in regulated environment.  For Associate Director: Bachelor’s degree with 10+ years of experience in regulated environment.
  • Ability to implement strategic initiatives and translate into tactical solutions; participates in planning strategic initiatives.
  • Experience in the use and application of technical standards, principles, theories, concepts, and techniques.
  • Familiar with the use of OE tools/lean manufacturing.
  • Knowledge of both US and international regulatory guidelines and standards.
  • Ability to set strategic vision from 1 month to 1 year.
  • Ability to independently identify and resolve relatively complex problems through good planning and decision making utilizing functional and technical skills.
  • Ability to manage conflict and stand alone on certain issues.
  • Ability to provide constructive feedback to staff.
  • Able to professionally communicate verbally, in writing and represent the function effectively.
  • Good listening skills, interpersonal savvy, and peer relations.
  • Ability to effectively present complex data and strategy in small meeting settings with clients, contractors and management groups. 

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2900. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.