Senior Quality Compliance Specialist

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Purpose:

The 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.

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

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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