Quality Compliance Specialist II
Albers Aerospace
Quality Compliance Specialist II
About this role
Company Description
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.
Job Description
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.
Qualifications
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.
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
Frequently Asked Questions
Is the salary disclosed for the Quality Compliance Specialist II position at abbvie?
The salary for this Quality Compliance Specialist II role at abbvie is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Quality Compliance Specialist II position at abbvie located?
This Quality Compliance Specialist II role at abbvie is based in Singapore, , Singapore. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Quality Compliance Specialist II role at abbvie full-time or part-time?
This is listed as a Full time position. It is posted as a Quality Compliance Specialist II role at abbvie.
How do I apply for the Quality Compliance Specialist II position at abbvie?
Click the "Apply Now" button on this page. You will be redirected to abbvie's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Quality Compliance Specialist II job at abbvie posted?
This Quality Compliance Specialist II position at abbvie was posted on Oct 14, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Compliance Specialist II
abbvie
You'll be redirected to abbvie's official application page on SmartRecruiters.