This is an exceptional opportunity for a high-energy Quality Professional to step into a leadership role and have a significant impact on the company. The Head Quality is a newly established role in the company and will be responsible for leading high-performing quality and compliance teams. The successful candidate will be a change-leader tasked with building a quality culture across the organization and strike a balance between implementing the processes and structure required to protect the organization’s assets while ensuring the business remains flexible and positioned for growth.
- Provide clear and concise vision for the quality and compliance
- Develop cross-company buy-in and ensure all teams exhibit a quality mindset.
- Facilitate interdepartmental communication to improve responsiveness and facilitate prompt decision-making.
- Attract, engage, and develop a high-performing quality team.
- Build team capacity through coaching and thoughtful career planning.
Quality and Compliance Strategies
- Provide leadership in the development and successful execution of the company’s quality management and compliance strategies, policies and plans.
- Advise the CEO on all compliance and quality related aspects of the company.
- Build high-trust collaborative relationships with the executive team to ensure strategic alignment of the quality and regulatory functions for the company.
Quality and Compliance Management
- Oversee effective day-to-day operations for the quality and compliance functions of the company.
- Establish a Total Quality Management system and drive it through the organization.
- Oversee the internal audit program and ensure compliance with all applicable regulations for medical device development and manufacturing operations.
- Guide internal teams to assure that all operational and development activities conform to business and regulatory requirements.
- Establishing and maintain relationships with key professionals and regulatory bodies.
- A bachelor’s degree in a scientific discipline
- 5-8 years’ experience in a quality leadership role
- Expert knowledge of regulatory strategy creation, design control, cGMP/Quality Systems and ideally with experience in FDA, EU, and ISO regulations and standards.
- Exceptional communications skills with the ability to gain buy-in with C-level executives as well as team members.
- High-energy, creative and with a collaborative working style
For more information, please contact
Tim Swanson email@example.com