Director, Quality - Remote - GXO Logistics Corporate Services, Inc.
High Point, NC 27260
About the Job
At GXO, we're constantly looking for talented individuals at all levels who can deliver the caliber of service our company requires. You know that a positive work environment creates happy employees, which boosts productivity and dedication. On our team, you'll have the support to excel at work and the resources to build a career you can be proud of.
We realize that it takes a great team to keep us at the top of the industry, so we're always looking for talented people like you to help us keep our operations running smoothly. As the Director, Quality Assurance, you will lead a team of QA champions with extensive industry experience and charged with developing and continuously improving the Quality Management System for our customer. You will be an integral part of solving complex business issues from strategy to execution, counted on to bring the QA perspective to consideration and to ensure the integrity of the QA program always remains unblemished. If you're ready to take your career to the next level, we have the opportunity for you to grow with GXO.
Pay, benefits and more.
We are eager to attract the best, so we offer competitive compensation and a generous benefits package, including full health insurance (medical, dental and vision), 401(k), life insurance, disability and the opportunity to participate in a company incentive plan.
What you'll do on a typical day:
- Develop a solid FDA quality organization across the organization with focus on 'zero defects' and improving the customer experience
- Lead a team of quality professionals across multiple sites to achieve corporate quality objectives and ensure ongoing compliance and sustainability of the Quality Management System
- Remain current with new regulations and standards including cGMP (21 CFR 110/111, 210/211), DEA, and ISO requirements; provide technical and quality leadership and support to all applicable sites and help prepare the organization for FDA and other compliance audits
- Actively maintain knowledge of current best practices of Pharmaceutical and Personal Health Care Product manufacturing
- Ensure key metrics and drivers of success are established, monitored and used to proactively identify areas for improvement to avoid QA shortfalls
- Develop a robust training program to keep QA top of mind, educate new associates, maintain proficiency, share lessons/best practices and rapidly shore up deficiencies
- Oversee all site QA Operations to ensure assessment of materials, in-process production, and shipment and sampling are performed consistent with cGMP
- Encourage a culture of continuous improvement; research the quality data generated at customer sites to identify opportunities for improvement, assess any adverse trends, and develop strategic action plans to ensure ongoing compliance with applicable regulatory and customer requirements.
- Handle quality improvement initiatives and utilize risk management principles to proactively identify areas of risk
- Continuously monitor the effectiveness of the Quality Management System and provide regular updates to the corporate leadership team on performance against quality metrics and goals
At a minimum, you'll need:
- 7 years of demonstrated experience working within the Healthcare (Pharmaceutical/Personal Care) industry
- Prior experience in managing Quality Management Systems registered to International Quality Standards (e.g. ISO 9001:2015, ISO 13485:2016, etc.)
- Demonstrated knowledge of applicable regulations such as FDA 21 CFR 110/111, 21 CFR 210/211, DEA, Health Canada and ISO 13485:2016 requirements
- Masters' Degree in Engineering, Microbiology, Biology or Chemistry
- 7 years of experience in a leadership role managing a Pharmaceutical/Personal Care or Animal Healthcare Site QMS
- Expertise in CAPA Reporting and Documentation
- Six Sigma/LEAN Certification
- Membership within an industry-related professional body (e.g. ASQ, etc.)
- Solid research skills, problem-solving ability and presentation skills
- Flexibility and ability to prioritize and manage multiple tasks simultaneously
- Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
- Proven ability to manage people, build relationships and understand what motivates others
- Excellent verbal and written communication skills with ability to tailor approach toward the perspective of others
- Demonstrated ability to interact effectively with individuals at all levels and working closely with others over geographical distance
- Solid attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
GXO is a leading provider of cutting-edge supply chain solutions to the most successful companies in the world. We help our customers manage their goods most efficiently using our technology and services. Our greatest strength is our global team - energetic, innovative people of all experience levels and talents who make GXO a great place to work.
We are proud to be an Equal Opportunity/Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, sex, disability, veteran or other protected status.
GXO adheres to CDC, OSHA and state and local requirements regarding COVID safety. All employees and visitors are expected to comply with GXO policies which are in place to safeguard our employees and customers.
All applicants who receive a conditional offer of employment may be required to take and pass a pre-employment drug test.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. All employees may be required to perform duties outside of their normal responsibilities from time to time, as needed. Review GXO's candidate privacy statement here.