Manager Quality Compliance (Complaints)

Regeneron Pharmaceuticals

1d • Onsite

About The Position

Regeneron is currently looking for a Manager, Quality Compliance (Compliant Investigations).This role will lead a team providing QA oversight of site compliance, with a primary focus on product quality complaint and trend investigations for commercial and clinical products. This role reviews and approves documentation, evaluates evidence and records (internal and external), designs experiments to test hypotheses, and authors technical reports/protocols to support investigation conclusions. The manager partners cross-functionally with Manufacturing (internal/external), Quality Control, Quality Assurance, and Global Patient Safety to meet regulatory requirements and site standards, advising on compliance best practices and stepping in as needed to meet timelines and resolve issues. As a Manager Quality Compliance, a typical day might include the following: Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; this work may be done through direct reports. Oversees investigations (product quality complaints and trending) related to dissatisfaction by end user related to commercial and clinical products. Provides guidance on investigation plans related to complaints documentations, photographic evidence, return samples and is available support investigations. Participates in regulatory and customer audits. Identify gaps in systems and develop feasible plans for correction Mentor direct reports and functional area counterparts in compliance requirements. Facilitating continuous improvement initiatives specific to function. Ensuring appropriate training programs are implemented for related to function. Other related responsibilities as assigned.

Requirements

• Have previous quality experience in the pharmaceutical industry
• You continuously seek to improve processes for improved performance
• Enjoy leading a team of Quality minded professionals
• Have knowledge/exposure to project management
• Have proficiency in Microsoft Office Programs
• To be considered for the Manager Quality Compliance you must be willing and able to work Monday-Friday, 8am-4:30pm.
• You must have a BS/BA in Life Sciences or related field.
• Manager, Quality Compliance: 7+ years
• May substitute proven experience for education requirement.

Responsibilities

• Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; this work may be done through direct reports.
• Oversees investigations (product quality complaints and trending) related to dissatisfaction by end user related to commercial and clinical products.
• Provides guidance on investigation plans related to complaints documentations, photographic evidence, return samples and is available support investigations.
• Participates in regulatory and customer audits.
• Identify gaps in systems and develop feasible plans for correction
• Mentor direct reports and functional area counterparts in compliance requirements.
• Facilitating continuous improvement initiatives specific to function.
• Ensuring appropriate training programs are implemented for related to function.
• Other related responsibilities as assigned.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager