Senior Director, Quality Operations

Life Unlimited.

At Smith+Nephew we design and manufacture technology that takes the limits off living. The Quality Sr. Director is responsible for overseeing the strategic and operational aspects of quality assurance and quality control functions at the FTW Vickery site. This includes ensuring the company's products meet regulatory, safety, and quality standards in compliance with Good Manufacturing Practices (GMP), FDA regulations, and other applicable regulatory requirements. The Quality Sr. Director will lead the quality team, drive continuous improvement, and collaborate with other departments to maintain high standards of product quality and patient safety.

What will you be doing?

Leadership and Strategy :

• Lead, mentor, and develop a high-performing quality team, fostering a culture of continuous improvement and excellence.
• Develop and execute the quality strategy, aligning with the company's overall business objectives.
• Establish clear quality goals and metrics to track performance, ensuring timely achievement of quality objectives.

Regulatory Compliance :

Quality Assurance and Control :

Cross-functional Collaboration :

Training and Development :

Documentation and Reporting :

What will you need to be successful?

Extensive knowledge of Good Manufacturing Practices (GMP), FDA

Minimum of 10 years of experience in pharmaceutical quality assurance or quality control, with at least 5 years in a leadership role.

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field (Master's degree preferred)

Experience leading regulatory inspections (e.g., FDA, EMA), with a proven track record of successful audits and compliance.

Experience in managing quality systems, investigations, CAPA, change control, and validation.

You Unlimited.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.