Job Summary

Lead Abbvie DSO, Compliance by promoting compliance mindset and awareness, Quality systems risk management, compliant state of both sites, inspection readiness, and oversight to ensure high levels of compliance with all relevant regulations and guidance. Ensure that the DSO organization operates in a compliant manner and is always inspection ready.

Job Details

This position is a key Compliance management role in  DSO and is responsible for the following duties:

• Responsible for oversight of internal and external compliance programs. These activities include oversight of internal and external compliance systems, GMP/GLP compliance, and approval of material suppliers and contract services (CMO, CLO). The basic requirement is to ensure that commercial and investigational materials are compliant with quality and regulatory requirements and standards.
• Responsible for overseeing and managing all aspects of regulatory and quality/corporate audits. Track all action items arising from the audits to ensure timely completion.
• Responsible for ensuring the sites are complying with all regulatory and GMP requirements.
• Ensure both DSO sites are implementing all aspects of the compliance systems as defined in the Abbvie policy and operational documents.
• Ensure the sites are in a state of inspection readiness by constant evaluation and assessment of compliance status of DSO sites and personnel. Ensure an inspection management plan/roadmap is in place with details such as room set ups, SME list with each area SME identified. Train SME and provide continuous refresher training for audits.  Perform GEMBA walks of all areas periodically to identify any Quality/Compliance issues in all areas.
• Responsible for the Internal audit program. This includes directing and planning the annual audit schedule, creating appropriate agenda per Abbvie procedures. Conducts training and coaching of auditors with respect to audit process, and documentation of findings. Supports auditee responses to observations and guides them for appropriate corrective actions and effectiveness check. Monitors the timely completion of corrective action plans. Ensures site leadership is provided with written reports of audit observations, responses and commitments.
• Reports Compliance metrics for Management Reviews.
• Is responsible  for maintaining the DSO supplier quality management program to

ensure it is operating in compliance with all requisite rules and regulations.

• Is responsible for leading the Data Integrity program to ensure compliance with all aspects of data integrity and security.

Incumbent has full authority to make decisions and/or take actions required to carry out job duties.  Abbvie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives.

Regulated Responsibilities (including cGMP and EHS)

Abbvie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Education and Experience:

Minimum requirements for this position are:

Essential Knowledge, Skills & Abilities:

• Working knowledge of regulatory compliance, Quality Systems, and experience working in a GMP environment.