Quality Assurance Director

Join a Leading Life Sciences Team!

Are you a seasoned Quality Assurance professional with a passion for excellence in the Life Sciences sector? We are excited to present an exceptional opportunity for an experienced and dynamic individual to step into the role of Quality Assurance Director. This is a permanent, full-time position based in North Carolina, designed for a motivated professional eager to elevate quality standards and drive success within an innovative organization. With a focus on medical devices and pharmaceuticals, this medium to small-sized company offers a dynamic work environment where your expertise will make a meaningful difference. If you have a proven track record of leadership, a strong background in quality systems, and deep knowledge of ISO 13485 compliance, this could be the perfect next step in your career journey.

Key Responsibilities:

As the Quality Assurance Director, you will play a pivotal role in ensuring the highest standards of quality and compliance within the organization. Your responsibilities will include, but are not limited to:

• Providing strategic leadership for all quality assurance initiatives, ensuring full compliance with ISO 13485 standards, which are critical for success in the medical device and pharmaceutical industries.
• Overseeing and managing quality systems to maintain regulatory compliance and operational excellence in the production and delivery of medical devices or pharmaceutical products.
• Driving and leading remediation efforts, identifying process gaps, and implementing improvements to enhance quality and align with regulatory requirements.
• Developing, mentoring, and empowering a team of quality assurance professionals, fostering a culture of continuous improvement and high performance within the department.

Desired Skills and Experience:

The ideal candidate for this role will possess a combination of technical expertise, leadership abilities, and hands-on experience in the Life Sciences sector. Key qualifications and attributes include:

• ISO 13485 Expertise: An in-depth understanding of ISO 13485 standards is not just beneficial but essential, as you will be the key driver of compliance and quality systems within the organization.
• Medical Device/Pharmaceutical Background: A strong professional background in the medical device or pharmaceutical industries is required. Familiarity with the unique challenges and regulatory requirements of these sectors will be instrumental in your success.
• Leadership Skills: Demonstrated experience in effectively managing and leading teams, particularly in medium to small-sized companies where collaboration and hands-on involvement are critical.
• Remediation Experience: Practical experience in leading and executing remediation projects to address compliance gaps, improve processes, and meet regulatory standards is highly valued.

In addition to these qualifications, we are seeking a candidate who is a natural problem-solver, highly organized, and capable of managing multiple priorities in a fast-paced environment. Strong communication skills and the ability to build relationships across all levels of the organization are also key to thriving in this role.

Why Join Our Client?

By joining our client, you will become part of a forward-thinking organization that is committed to advancing innovation and maintaining the highest standards in the pharma industry. This role offers a unique opportunity to make a significant impact on the quality and compliance of our products while contributing to the growth and success of the company. With a supportive leadership team and a collaborative work environment, you will have the resources and autonomy you need to excel.

If you are ready to take on the challenge of ensuring top-tier quality standards, driving continuous improvement, and shaping the future of innovation in the Life Sciences sector, we invite you to apply now.