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.