Quality Compliance Specialist (Partner Change Control Notifications)
Regeneron
4 hours ago
On-site
Troy, NY
Operations
Quality Compliance Specialist (QA Change Control Team)
Responsibilities:
- Act as Regeneron’s representative in meetings with external partners to discuss changes for applicable products
- Participate in internal cross-functional teams on global change management of partnered products
- Sponsor and advocate for Continuous Improvement; develop and implement updates to the Change Control Partner Notification Process and associated procedures (with Quality Assurance team members and/or system end users)
- Build relationships with end users; provide best-practice guidance/strategy for changes requiring partner notification
- Develop, monitor, and communicate metrics to ensure the health of the partner notification process
- Partner with counterparts to ensure global alignment of processes, systems, and procedures
- Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
- Assist as needed in audits and inspections
- Review and approval of Partner Change Notifications
Qualifications / Requirements:
- Knowledgeable in Biotech/Pharmaceutical Quality systems, including cGMP and FDA regulations; familiarity with ICH guidelines and global regulatory requirements
- Ability to perform independent work with attention to detail, accuracy, scientific judgment, and the ability to shift quickly between tasks
- Aptitude to comprehend, analyze, and interpret process/system information, technical procedures, reports, and regulations to make decisions in a GMP environment
- Proven track record of establishing/maintaining effective working relationships and influencing individuals at various levels
- Excellent interpersonal, written, and oral communication skills; strong active listening
- Proficient in Microsoft Word, Excel, PowerPoint, and SharePoint; Quality Management Systems experience preferred
Education & Experience:
- Bachelor’s in a scientific or related field
- Minimum relevant experience:
- Associate Specialist: 0+ years
- Specialist: 2+ years
- Senior Specialist: 5+ years
- Change Control function experience strongly preferred
- May substitute proven experience for education requirement; level determined based on role-relevant qualifications
Application Instructions:
- Apply now
Responsibilities:
- Act as Regeneron’s representative in meetings with external partners to discuss changes for applicable products
- Participate in internal cross-functional teams on global change management of partnered products
- Sponsor and advocate for Continuous Improvement; develop and implement updates to the Change Control Partner Notification Process and associated procedures (with Quality Assurance team members and/or system end users)
- Build relationships with end users; provide best-practice guidance/strategy for changes requiring partner notification
- Develop, monitor, and communicate metrics to ensure the health of the partner notification process
- Partner with counterparts to ensure global alignment of processes, systems, and procedures
- Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
- Assist as needed in audits and inspections
- Review and approval of Partner Change Notifications
Qualifications / Requirements:
- Knowledgeable in Biotech/Pharmaceutical Quality systems, including cGMP and FDA regulations; familiarity with ICH guidelines and global regulatory requirements
- Ability to perform independent work with attention to detail, accuracy, scientific judgment, and the ability to shift quickly between tasks
- Aptitude to comprehend, analyze, and interpret process/system information, technical procedures, reports, and regulations to make decisions in a GMP environment
- Proven track record of establishing/maintaining effective working relationships and influencing individuals at various levels
- Excellent interpersonal, written, and oral communication skills; strong active listening
- Proficient in Microsoft Word, Excel, PowerPoint, and SharePoint; Quality Management Systems experience preferred
Education & Experience:
- Bachelor’s in a scientific or related field
- Minimum relevant experience:
- Associate Specialist: 0+ years
- Specialist: 2+ years
- Senior Specialist: 5+ years
- Change Control function experience strongly preferred
- May substitute proven experience for education requirement; level determined based on role-relevant qualifications
Application Instructions:
- Apply now