Quality Compliance Associate

• Our Global Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”

• Contract Operations Quality Assurance (COQA) drives excellence in Quality by maximizing our Partner collaboration to ensure Patients confidence in our Products.

• COQA is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.

• The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM), management of routine complaints and execution of lot disposition activities for the Drug Products and Drug Substances (APIs) manufactured by COQA managed Contractors.

• Initiate, review and approve regulatory changes through the Regulatory Compliance Change Manager (RCCM) system and Product Dossier Manager (PDM) for changes initiated by or impacting COQA managed contractors. 

• Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations. 

• Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs (for Single market products) for the various regulatory activities involving the COQA managed contractors. As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for COQA managed contractors and if needed, participate in Site Quality visits at the contractors. 

• Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable.

• Ensure timely closure of complaints and alerting the appropriate colleagues for the confirmed complaints.