Senior Quality Compliance Specialist II

The Senior Quality Compliance Specialist II is responsible to:

• Support the development and lead in the maintenance of site quality compliance programs to ensure site adherence to AbbVie Policies, and current Good manufacturing practices (cGMP) requirements per regulatory standards.
• Serve as Subject Matter Expert for site quality compliance programs for Internal Audit and External Inspection Management, Regulatory Affairs Submission, Quality Manual/ Site Master File, Quality Risk Management and Data Governance.
• Lead in continuous improvement initiatives to safeguard quality processes and promote a culture of compliance within the organization.

Major Responsibilities:

Internal and External Inspection Management

• Lead and act as Subject Matter Expert in inspection management to ensure site inspection readiness for regulatory inspection in Pre-Approval Inspection or GMP surveillance inspection.
• Qualified internal lead auditor to perform self-inspection independently and lead in improvement initiatives to mitigate compliance gaps.
• Drive Compliance Partner Program, in assigned site departments, to ensure compliance to the requirements of applicable regulations that pertain to pharmaceutical and biopharmaceutical Manufacturing.

Compliance Systems Management

• Proficient in Quality Manual/ Site Master File, Quality Risk Management and Data Governance.
• Implement initiatives in collaboration with site functional areas/departments to drive continuous improvement in compliance systems.
• Participate in Quality Center of Excellence (COE) discussions and provide site feedback

Regulatory and Filing Submission Management

• Primary contact as site regulatory submission liaison for product filing activities, and support the maintenance of HSA Manufacturing Licenses and GMP certification from relevant regulatory agencies, as assigned.
• Prepare, maintain and facilitate periodic review of Site Master File and Quality Manual

Data Governance

• Site coordinator for Data Governance – Trainer for data integrity and Subject Matter Expert for associated procedures (e.g. Data integrity Risk Assessment, Audit Trail Review), as assigned.
• Support and advice employees in the execution of integrity initiatives and topics

Quality Risk Management

• Site coordinator to provide oversight, technical expertise and training in quality risk management throughout the organization, as assigned
• Formulate and review strategies for risk controls and mitigations, facilitate quality risk-based programs supporting the Quality System.