Associate Director, IT Quality Assurance

Rensselaer, NY, United States
Dec 30, 2020
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill an Associate Director IT Quality Assurance position. This position is responsible for providing leadership and functional oversight for quality operations supporting technology globally at Regeneron manufacturing facilities.

In this role, a typical day might include the following:
• Designing and maintaining an industry leading approach to computer systems validation
• Leading the development of processes and systems that drive compliance to critical regulatory requirements
• Developing and maintaining a comprehensive and compliant data integrity approach across sites
• Planning and conducting quality audits supporting IT/IS
• Collaborating with management to ensure understanding and acceptance of the roles and responsibilities of the organizations supporting information technologies and systems
• Promoting GXP and quality approach at all levels
• Ensuring appropriate execution of validation strategies and compliance with internal procedures
• Leading and maintaining the transparency of any noted deviations or deficiencies through trend and root cause analysis; and work with the appropriate teams and functions to implement robust CAPAs
• Ensuring that all quality work associated with IT and IS comply with regulatory and quality policies and procedures
• Participating in FDA and other regulatory inspections, and leads presentation strategy development for CSV and IT Quality related topics
• Keeping current on regulatory requirements and work with other functions to incorporate into systems
• Interviewing, hiring, on boarding, and training incoming personnel, leading staff as assigned to work with project teams
• Ensuring direct-report staff is appropriately resourced, supported and has the tools and direction to accurately execute their function
• Traveling up to 15% (domestic and international)

This role may be for you if you:
• Have detailed knowledge of cGXPs
• Demonstrate a proactive approach to Computer System Validation
• Possess excellent leadership and management skills

To be considered for this role you must hold a Bachelor's degree in life sciences with 8+ years of relevant experience in an FDA regulated industry, with at least 5 years in management for Sr Manager level, 10+ years of relevant experience for Associate Director level and 12+ years of relevant experience for Director level. Quality assurance and IT experience preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.