This Senior Director of Quality Assurance in Carlsbad, CA is responsible for working with the Leadership team to build a Quality vision that is aligned with the business strategy of our fast growing and evolving Clinical Sciences Division. You'll lead a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing training and development opportunities to the team.
- Oversight of 5 sites including R&D.
- Over 100 people within your team.
- Ability to work with a wide variety of products including Class III IVD as well as research-use only products.
- Role covers everything from NPI and R&D QA through commercial Manufacturing.
- Key leader within the organization.
Senior Director Quality Assurance Job Responsibilities:
- Coach, motivate, and communicate to a mix of RUO (ISO 9001), CE-IVD (13485), and GMP (21CFR820) Quality Assurance teams (sites).
- Develop and communicate a Quality vision and strategic objectives that aligns with the LSG and CSD operations and business strategy.
- Set network wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality Management System.
- Oversee global Quality Control team performance to meet standard turnaround times, QC test first pass yield (test/retest error), OOS actions, and labor efficiency.
- Ensure global training is effective and that the plants operate within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
- Ensure effective management of quality objectives across multiple sites across the globe in within the Clinical Sciences Division of the Life Sciences Solutions Group.
- Set clear roles and responsibilities across the network with pro-active management controls.
- Actively coach technical professionals to achieve maximum performance.
- Ensure effective management of the network / site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support.
- Provide global quality system leadership to assure internal policies, customer expectations and regulatory requirements are met.
- Leads quality system executive quality management reviews.
- Oversee the continuous improvement of Quality Management Systems at sites around the world, including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, validation, and manufacturing area support.
- Responsible for Design Compliance team members supporting the commercialization of NPI's emerging of R&D.
- Closely partner with the Global Regulatory organization to ensure compliance to applicable regulations.
- Engage with network leadership and business partners to define the existing gaps and future requirements for Quality Management System.
- Effectively use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.
- Significant knowledge and insight into qualification and validation activities and the ability to partner effectively with engineering and operations teams in completing these tasks.
- Influence and build strong working relationships across organizations and geographies.
- Bachelor's degree in a Science or Engineering Discipline.
- 10+ years of Quality experience within the Medical Device, Pharmaceutical or Clinical Testing industries.
- Experience with In Vitro Diagnostics.
- Decisive leader who's successfully managed larger teams in a highly matrixed organization.
- Demonstrated experience working with external customers and commercial teams creating strategies that address customer needs and product specification.
- Previous experience working global teams and applying global business acumen.
- Proven experience with Project Management and Lean Six Sigma methodology.
- Previous experience supporting Medical Device or Pharmaceutical New Product Introductions preferred.
Sthree US is acting as an Employment Agency in relation to this vacancy.