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Site Quality Director

Site Quality Director

GSKRockville, MD, US
11 days ago
Job type
  • Full-time
Job description

Site Quality Lead Director

Are you looking for an opportunity to lead and inspire Site Quality teams toward the pursuit of operational excellence in manufacturing practices while building a high-performance network? If so, this is the role for you.

As Site Quality Lead Director, you will provide strategic leadership and direction for the site's Quality function, ensuring the highest standards of product quality and compliance with GSK corporate policies and regulatory standards. The role is accountable for the quality of all products released from the site and for representing GSK in health authority interactions.

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following :

  • Strategy Deployment : Serve as a member of the site leadership team, actively contributing to strategy deployment to support GSK objectives.
  • Quality and Compliance Strategies : Develop and implement quality and compliance strategies and initiatives, ensuring full deployment of GSK's Quality Management System (QMS).
  • Continuous Improvement Culture : Foster a culture of continuous improvement, developing and monitoring key quality metrics to drive performance.
  • Quality Leadership : Provide leadership and direction in all Quality related matters, ensuring operational business compliance with cGMP and regulatory requirements.
  • Team Development : Lead and develop the Quality organization on site, making decisions that prioritize patient safety and product quality.
  • Strategic Quality Planning : Develop and execute a long-term quality strategy that aligns with the overall business objectives, ensuring that quality considerations are integrated into the site's strategic planning and decision-making processes.
  • Regulatory Compliance : Maintain a state of inspection readiness by staying abreast of regulatory changes and trends, and ensuring that the site's quality systems and processes are robust and compliant with current industry standards and practices.
  • Quality Culture and Employee Development : Champion a strong quality culture throughout the site by promoting quality awareness, accountability, and continuous improvement. Develop and mentor quality personnel to build a pipeline of talented quality professionals capable of supporting the site's current and future needs.

Leadership Competencies :

  • Patient Focus : Lead with a patient-centric approach in all quality-related decisions and actions.
  • Integrity : Uphold the highest ethical standards, ensuring transparency and honesty in all operations.
  • Respect for People : Foster an inclusive environment that values diversity and encourages collaboration and innovation.
  • Do the Right Thing : Demonstrate the courage to make tough decisions and challenge the status quo in the best interest of patients and the company.
  • Basic Qualifications :

  • Bachelor's Degree with 10 plus years of experience in pharmaceutical OR biological production environments
  • Experience with FDA / EU / ICH / CDN / AUS guidelines
  • Leading First & Second Line Managers
  • Experience working with Site Leadership Team
  • Experience with patient safety and product quality
  • Preferred Qualifications :

  • Experience in leading cross-functional teams and driving organizational change
  • Excellent interpersonal and communication skills, with the ability to engage effectively with stakeholders at all levels
  • Strong knowledge of good manufacturing practices and data integrity
  • Demonstrated ability to challenge the status quo and drive continuous improvement
  • Ability to make risk-based and autonomous decisions
  • This position is located onsite in Rockville, MD.

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