Senior Quality Compliance Specialist II

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