Quality Compliance Specialist II

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About the role

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.h

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