Director of Quality Assurance (QA) in pharmaceuticals at Bevov in Fort Worth, Texas

Posted in Retail 15 days ago.





Job Description:

Key Responsibilities:

  • Sets the direction for the entire QA, QC, Microbiology, QMS, Process Validation, and Cleaning Validation departments at the Fort Worth, Dallas, TX site.
  • Creates, leads, and manages Site Quality Compliance, Risk Management activities, including Quality Council Presentation, Quality Program, Training Program, Validation Program, complaint management, and Audit readiness.
  • Work with multi-functional technical teams and provide guidance on GMP requirements for bringing innovation to the site to deliver business growth.
  • Collaborates with other functional leaders and be part of Fort Worth, Dallas site leadership to lead the overall organization and drive a culture of quality and compliance.
  • Manages the staffing and career planning of 20+ direct & indirect reports and be part of a capable and compliance-focused QA team.

Passionate and driven individual who:

  • Is a creative thinker with exceptional process, analytical, management, and relationship skills.
  • Is calm and decisive under challenging conditions with the ability to make independent, reasoned decisions.
  • Has the ability and desire to inspire and to align teams, critical resources, management, and stakeholders in support of delivering business objectives.
  • Is an effective influencer, collaborator, and strategic planner able to lead at all levels of the organization with a proven ability to lead in a complex environment

Requirements

Required:
  • Bachelor's Degree or higher in Pharmacy, Chemistry, Engineering, or related field.
  • Experience and direct interaction with regulatory bodies involving cGMP activities (i.e., hosting audits, preparing responses, etc.)
  • 20 to 25 years of industry experience in Quality Assurance in pharmaceuticals and/or dietary supplements.
  • Five to ten years' experience as a QA Director.
  • 5+ years managing a quality assurance organization at a production plant.
  • Working knowledge of quality system requirements.
  • Experience with MS Word, Excel, Project Management, and Analytics Software.
  • Ability to relocate to Fort Worth, Dallas, TX.

Preferred
  • Experience in managing a quality assurance organization of similar size, scope, and complexity as required for this role.
  • Building the system and /or processes from the scratch.
  • Continuous Improvements, Systems and /or Processes, CAPA Management, and Data Integrity Knowledge.
  • Experience and knowledge of writing, reviewing, editing, and approving the complex investigation.