Job Description

Our client is a global leader in the healthcare and pharmaceutical industry, dedicated to discovering and delivering innovative medicines that address serious health issues and future medical challenges. They have a significant impact on peoples lives across various therapeutic areas with a commitment to excellence and innovation.Job SummaryThe Quality Manager role entails comprehensive responsibility for the QA Documentation and Training Area, including personnel organization, training, development, and supervision. This position is vital for developing, implementing, and maintaining the effectiveness of the quality system, ensuring compliance with global regulatory requirements.Responsibilities

• Personnel Management: Hire, train, develop, and evaluate the performance of personnel in the QA Documentation and Training Area, maintaining an organizational structure that meets immediate and long-term objectives.
• Quality System Oversight: Own the Management Review process, ensuring the effectiveness of the quality system across Quality Documentation, Training, and Supplier Quality departments.
• Compliance and Strategy: Ensure adherence to AbbVie policies, contributing to strategy development and overseeing complex programs to maintain global regulatory compliance.
• Program Management: Lead broad, cross-functional quality initiatives and organizational changes related to the quality system, managing resources and prioritizing effectively.
• Training Program Management: Establish and maintain a CGMP training program, ensuring all personnel are adequately trained.
• Documentation Control: Oversee documentation control quality programs, including Document Change Control and Batch Record Archive.
• Supplier Quality Management: Administer and maintain supplier quality programs, including CAPA system oversight and Supplier Qualification.
• Cross-Functional Support: Support QC, Engineering, Quality Systems, and Operations to achieve site goals, participating in or chairing project team meetings.

• A Degree or Higher in Science or Engineering discipline, with a Quality or Regulatory Qualification being an advantage.
• At least 5 years of experience in a Quality or Project/Program Leadership role within a pharmaceutical or biopharmaceutical GxP environment.
• Strong communication skills and excellent knowledge of pharmaceutical regulatory requirements (GMP).
• Minimum of 2 years of leadership experience in project leadership or people management roles.
• Demonstrated capability as a change agent, innovative thinker, and proficiency in PMP software skills (e.g., MS Project, Mind Manager).
• Experience in managing diverse teams, with a strong problem-solving ability, independence, and meticulous attention to detail.

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