Quality Compliance Specialist II

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.

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.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html