Quality Compliance Specialist (Partner Change Control Notifications)

Regeneron Pharmaceuticals

6d • Onsite

About The Position

We are currently looking to fill a Quality Compliance Specialist position. This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. In this role, a typical day might include the following: • Acting as Regeneron’s representative in meetings with external partners to discuss changes for applicable products • Participating in internal cross functional teams on global change management of partnered products • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures • Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification • Developing, monitoring, and communicating metrics to ensure the health of the partner notification process • Partners with counterparts to ensure global alignment of processes, systems, and procedures • Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation • Assisting as needed in audits and inspections • Review and Approval of Partner Change Notifications This role might be for you if you: •Are knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory •Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another • Have aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment •Have a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan •Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships •Are proficient in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint, experience with Quality Management Systems preferred To be considered for this role you must hold a Bachelor's in a scientific or related field and the following minimum amounts of relevant work experience for each level: Associate Specialist - 0+ years Specialist - 2+ years Senior Specialist - 5+ years Experience in change control function strongly preferred. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

Requirements

• Are knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
• Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
• Have aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
• Have a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
• Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
• Are proficient in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint, experience with Quality Management Systems preferred
• To be considered for this role you must hold a Bachelor's in a scientific or related field and the following minimum amounts of relevant work experience for each level: Associate Specialist - 0+ years Specialist - 2+ years Senior Specialist - 5+ years

Nice To Haves

• Experience in change control function strongly preferred.
• May substitute proven experience for education requirement.

Responsibilities

• Acting as Regeneron’s representative in meetings with external partners to discuss changes for applicable products
• Participating in internal cross functional teams on global change management of partnered products
• Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures
• Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification
• Developing, monitoring, and communicating metrics to ensure the health of the partner notification process
• Partners with counterparts to ensure global alignment of processes, systems, and procedures
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
• Assisting as needed in audits and inspections
• Review and Approval of Partner Change Notifications

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees