Senior Manager, Quality Compliance

Senior Manager, Quality Compliance

Under the direction of the Senior Director of Quality, the Senior Manager, Quality Compliance is responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems : Supplier Management, Internal and External Audits, Electronic Quality Management Systems, Customer Complaints, Adverse Events, Product Recall, Field Alerts and Regulatory Surveillance. Support audits / inspection processes, including, but not limited to : governmental, regulatory, Corporate or vendor audits and audit readiness related activities. This position is located in Monroe, NC and requires approximately 10-15% travel.

Overall Job Responsibilities

• Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
• Maintain quality compliance system controls to ensure state of compliance and no critical and major market complaints, which includes, but is not limited to, the following systems : Supplier Management, Internal and External Audits, Electronic Quality Management Systems, Customer Complaints, Adverse Events, Product Recall, Field Alerts and Regulatory Surveillance.
• Ensure that all statutory and regulatory compliance are regularly monitored and is in a state of compliance as applicable.

Operational Excellence

Stakeholder

Innovation

Knowledge, Skills and Abilities

Education

Experience

Knowledge and Skills (Functional / Technical)

Leadership / Managerial Attributes

Other requirements (licenses, certifications, specialized training)