Senior Quality Compliance Specialist II
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Job Location:
Monthly Salary:
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
