Sr Director, Quality Assurance NAM
New Yesterday
The Sr. Director, Quality Assurance will provide quality leadership to the Health & Nutrition, Life Sciences North America business to ensure compliance with regulatory authority requirements and to ensure sites are meeting or exceeding customer quality expectations.
Provide strategic leadership to the Quality group for sustained quality system programs with a continuous focus on improvement
Lead and inspire the Quality Function by establishing Quality policies that are uniformly deployed across the business
Educate, motivate, and empower employees across all functions and operations in the development of a Customer-Focused Quality Culture
Ensure that processes needed for the QMS are effectively established, implemented, and effectively maintained; reporting to executive management on the performance and effectiveness of the QMS for review and any need for improvement
Ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization
Ensure that all sites are inspection or audit-ready and support global regulatory inspections and third-party audit program
Trend, analyze and report on QMS compliance and performance to the Global Head of Quality
Identify critical compliance and/or business issues related to quality. Create and execute remediation strategies and tactical plans as needed using a risk management-based approach
Develop strategically and operationally effective response plans to Third Party/Customer audit findings
Conduct investigations and internal audits on behalf of the Global Quality Excellence team
Identify and immediately report potential risks that may impact service and the business
Qualifications
Four-year degree from an accredited college or university
In-depth knowledge and experience managing GMP
15+ years of experience working in Quality Assurance int eh pharmaceutical industry
7+ years of managing Quality Assurance teams at the Director level
Demonstrated communication, leadership, and management skills
Track record in successfully hosting FDA and Health Authority inspections
Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growing, dynamic environment
Demonstrated problem solving and critical thinking skills
Experience in technology transfer and management of contract research operations
Able to work outside of regular working hours and occasional weekends for travel to lab operations sites
Our Benefits
We care about your total well-being and will support you with the following, subject to your location and role.
Health: Medical, dental and vision insurance, life insurance, employee wellness programs
Wealth: Competitive pay, 401(k) with company match (immediate vesting upon enrollment), employee referral program, annual bonus target
Happiness: Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program Work-Life Balance: Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)
- Location:
- Lincolnshire
- Job Type:
- FullTime