Logistics done differently.
Ranked as the #1 North American logistics company according to Transport Topics, XPO Logistics is among the most admired companies in the world according to Fortune Magazine. 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 Quality Assurance Director, 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 XPO.
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 strong 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
- R emain 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
- Drive a culture of continuous improvement ; analyze 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.
- Manage 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
What you need to succeed at XPO:
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
It'd be great if you also have:
- 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
- Ability to travel up to 50%
- Lean Six Sigma Black Belt
- Membership within an industry-related professional body (e.g. ASQ, etc.)
- Strong analytical 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
- Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
Be part of something big
XPO 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 XPO 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.
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.