Site Quality Director

GlaxoSmithKline • Rockville, MD

117d • $201,300 - $335,500

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Serve as a member of the site leadership team, actively contributing to strategy deployment to support GSK objectives.
• Develop and implement quality and compliance strategies and initiatives, ensuring full deployment of GSK's Quality Management System (QMS).
• Foster a culture of continuous improvement, developing and monitoring key quality metrics to drive performance.
• Provide leadership and direction in all Quality related matters, ensuring operational business compliance with cGMP and regulatory requirements.
• Lead and develop the Quality organization on site, making decisions that prioritize patient safety and product quality.
• Develop and execute a long-term quality strategy that aligns with the overall business objectives.
• Maintain a state of inspection readiness by staying abreast of regulatory changes and trends.
• 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.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver/parental and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree