Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 Product Complaints, Recall Management, Quality Manual/ Site Master File, Management Review, Quality Metrics, Quality Risk Management, Data Governance and Quality Plan management.
• 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.

Qualifications

• Bachelors / Masters in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent.
• A minimum of 8 years in a cGMP regulated environment is required.
• A minimum of 3 years of relevant experience in compliance and audit is required.
• Specialization in quality / compliance areas such as audit management, quality risk management and data governance in either small molecule API or Biologics manufacturing is preferred.
• Strong knowledge of regulatory standards and guidelines (such as ICH, CFR, Eudralex, PIC/S) is required.
• Proven problem-solving skills and the ability to adapt to changes is required.
• Strong communication skills both verbal and written are required.
• Strong interpersonal and stakeholder management skills are required.
• Ability to lead and influence cross-functional teams is preferred.
• Strong presentation skills are preferred.

Additional Information

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