Title: Vice President of Quality

Job Summary

The Vice President of Quality will provide strategic oversight of the Quality functions for the company. The Vice President will lead, establish, implement and maintain Quality programs, procedures, and controls ensuring conformance with cGMPs as well as regulatory and industry standards for commercial pharmaceutical API and pharmaceutical dosage form products. This individual will also provide technical and organizational leadership to QA/QC/Compliance and documentation control programs and activities and expand the group by providing leadership and value-added services to the company. This person must have the ability to manage multiple departments and projects. Additionally, the incumbent will have experience working with contract manufacturing organizations or contract laboratories with a track record of on-time delivery of results. Working in cooperation with colleagues from R&D, Marketing, Operations, Manufacturing and Regulatory, this position will develop, evaluate and shape the strategy for continuous improvement within facilities and training excellence.

The Vice President of Quality will also work with peers and colleagues throughout the Company to continually redefine and improve the overall quality culture of Frontida sites, businesses and operations.

 

 

Responsibilities

  • Strong contributor to the development and implementation of Frontida’s corporate quality strategy
  • Ensure the development and implementation of best practices for quality systems activities by working with peers, senior management and team leaders from cross functional areas to continually define and develop system improvements in line with business strategy
  • Ensure that the company facilities have the quality resources to fulfill the corporate strategy. Lead and participate in site Quality Management Reviews, customers, and regulatory agency, DEA  and Notified Body audits whenever possible
  • The incumbent will have oversight of training and development programs for Quality Systems personnel
  • Lead activities with regulatory bodies (e.g. FDA) and Customers with a view to enhancing the profile and the perception of Frontida as an ethical, responsible and compliant corporation by such regulators
  • Work strategically to align quality activities throughout the company
  • Ensure the promulgation of consistent quality systems activities across the company
  • Develop strong relationships with corporate partners and customers, including suppliers, distributors and end-users, to ensure design, supply and maintenance of quality products and practices
  • Maintain an excellent knowledge of industry requirements, regulations and best practices in relation to Quality Manages staff and carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, training employees; planning, assigning, and directing work; appraising performance, counseling employees; addressing complaints and resolving problems
  • Perform other duties as assigned

Knowledge and Skills

  • Bachelor’s degree (Advanced degree a plus) in Chemistry or related science
  • 15 years’ related management experience in C laboratory in the pharmaceutical industry or equivalent combination of education, training and experience
  • Strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams
  • Ability to develop solutions to technical challenges and implement recommendations in a timely fashion
  • Experience using contract vendors.
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