Quality Compliance Specialist II

The Quality Compliance Specialist is responsible to

• Support the execution of site quality compliance programs to ensure site adherence to AbbVie Policies, and current Good manufacturing practices (cGMP) requirements per regulatory standards.
• Support site quality compliance programs for Internal Audit and External Inspection Management, Regulatory Affairs Submission, Product Complaints, Recall Management, Quality Manual/ Site Master File, Management Review, Quality Metrics, Quality Risk Management, Data Governance and Quality Plan management, as assigned.

Major Responsibilities

Internal Audits and External Inspection Management

• Support in inspection management activities to ensure site inspection readiness for regulatory inspection in Pre-Approval Inspection or GMP surveillance inspection.
• Support internal lead auditor to perform self-inspection as co-auditor
• Support 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

• Support in activities for Product Complaints, Recall Management, Quality Manual/ Site Master File, Management Review, Quality Metrics, Quality Risk Management, Data Governance and Quality Plan management.
• Support initiatives in collaboration with site functional areas/departments to ensure inspection readiness in operations

Regulatory and Filing Submission Management

• Assist in regulatory submission activities for product filing, and maintenance of HSA Manufacturing Licenses and GMP certification from relevant regulatory agencies, as assigned.
• Assist in maintenance of Site Master File and Quality Manual

Data Governance

• Support and assist in promotion and training Trainer for data integrity and associated procedures (e.g. Data integrity Risk Assessment, Audit Trail Review), as assigned.

Quality Risk Management

• Support and assist in data collection or tracking of Quality Risk Management activities, as assigned

Product Complaint and Recall Management

• Support and assist in mock recall annual exercise including planning and execution of the plan, as assigned

Quality Plan

• Support and assist in data collection or tracking of Quality Plan activities, as assigned.

Education

• Bachelors / Masters in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• A minimum of 2-5 years in a cGMP regulated environment is required.
• A minimum of 2 years of relevant experience in compliance and audit is preferred.
• Specialization in quality / compliance areas such as audit management, product review, customer complaints, management review, quality metrics, quality risk management and data governance in either small molecule API or Biologics manufacturing is preferred.
• Good knowledge of regulatory standards and guidelines (such as ICH, CFR, Eudralex, PIC/S) is preferred.
• Proven problem-solving skills and the ability to adapt to changes is preferred.
• Strong communication skills both verbal and written are required.
• Strong interpersonal skills are preferred.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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