Job Description

Purpose Statement Senior Quality Compliance Specialist is responsible to support the development and maintenance of Audit 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 related Quality Management system to comply with all applicable regulatory requirements and AbbVie’s Quality Policies and Procedures. Major Responsibilities:

• Lead and act as Subject Matter Expert in inspection management for internal and regulatory inspection. Activities including inspection preparation, execution and post audit follow up.
• Qualified internal lead auditor to perform self-inspection independently
• Lead and act as Compliance Partner to work with cross functional team to ensure inspection readiness in operation.
• Primary contact as site product complaints liaison to ensure the global procedure is adhered, as assigned.
• Primary contact as site recall liaison and responsible to plan and execute annual mock recall exercise as per procedure requirement, as assigned.
• Primary contact as site regulatory submission liaison for product filing activities, as assigned.
• Prepare, maintain and facilitate periodic review of the GMP documentations (e.g Site Master File, Quality Plans, PQRs, etc) to ensure the adherence of compliance requirement.
• Developing and maintaining performance measurement / Quality Index, ensure Quality Management Reviews are performed per internal procedure.
• Promotion of data integrity and further supporting tools and procedures (e.g. Data integrity assessment, procedure and Q&A) to create awareness through communication (e.g. promoting the integrity portal and trainings). Support and advice employees in the execution of integrity initiatives and topics.
• Develop and improve the Quality Risk Management program across a full spectrum of processes vital to the operations. Formulate strategies for risk controls and mitigations, facilitate quality risk-based programs supporting the Quality System. Provide oversight and technical expertise in quality risk management throughout the organization

Qualifications: Education

• Bachelor Degree in Sciences (e.g. Biology, Chemistry), Pharmacy, or Engineering Degree or equivalent

Experience

• Specialize 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.
• Minimum 6+ years working experience in (GxP) environment is required and in quality areas is required

Skills

• A strong knowledge of regulatory requirements is required
• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures
• Requires proven problem solving skills and the ability to adapt to new regulatory requirements
• Ability to quickly know products and processes in order to assess quality issues
• Strong communication skills both verbal and written are required for the execution of this role
• Strong presentation and interpersonal skills is required
• Shows a high level of tenacity to ensure closure of issues and projects assigned
• Ability to lead and train up less experience compliance personnel

Key Stakeholders:

• Abbvie Operations Singapore cross functional groups including, API and Bio Manufacturing, Engineering, Supply Chain, IT, Technical Operation, Quality Control and Quality Assurance team.
• COE lead for Compliance Quality Systems