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:

• Ensure compliance with FDA and other regulatory bodies' requirements and standards for pharmaceutical manufacturing and distribution.
• Manage and oversee regulatory inspections, audits, and submissions.
• Maintain and update internal quality systems to remain in compliance with changing regulations.

Quality Assurance and Control:

• Oversee all quality assurance functions including batch record review, CAPA (Corrective and Preventive Actions), and change control processes.
• Direct the Quality Control (QC) operations to ensure the testing of raw materials, in-process materials, and finished products meet specifications.
• Implement and manage risk management systems related to quality and manufacturing operations.

Cross-functional Collaboration:

• Collaborate with R&D, Production, Regulatory Affairs, and Supply Chain teams to ensure seamless integration of quality systems throughout the product lifecycle.
• Work closely with manufacturing operations to troubleshoot issues and improve product quality.

Training and Development:

• Ensure the quality team and other relevant departments are well-trained on quality standards, processes, and regulatory requirements.
• Stay current with industry trends, new technologies, and evolving regulatory requirements, and incorporate relevant changes into quality systems.

Documentation and Reporting:

• Ensure proper documentation of quality-related activities, including batch records, deviation reports, and validation protocols.
• Prepare and present regular quality performance reports to senior management, identifying risks and opportunities for improvement.

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.

• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 
• Flexibility: Hybrid Work Model (For most professional roles)  
• Training: Hands-On, Team-Customized, Mentorship  
• Extra Perks: Discounts on fitness clubs, travel and more!  

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.