Senior Manager, IT Quality Assurance

Company Description

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.

Job Description

 The Senior IT Quality Manager will elevate compliance and process excellence by ensuring adherence to regulatory requirements and corporate procedures. This role involves strategizing and implementing advanced quality system requirements, as well as leading high-impact, cross-functional initiatives to drive continuous improvement. Serving as an essential liaison between diverse business units and the BTS (Business Technology Solutions) Quality organizations, the Senior IT Quality Manager will establish and manage critical partnerships and contracts, ensuring alignment with business objectives and compliance standards. The ideal candidate will have a keen ability to influence stakeholders, leverage data for impactful decisions, and ensure operational excellence in a dynamic, highly regulated environment.

Focused on Infrastructure, Platform, and Application quality, the senior role involves spearheading compliance enhancement projects and supporting internal audits and IT investigations. Additionally, the role will play a pivotal role in long-range strategic planning and budgeting to ensure that IT quality and regulatory initiatives align with AbbVie's business goals and future growth.

SQA - This role emphasizes the adoption of modern validation approaches such as Computer Software Assurance (CSA) and ensures compliance while optimizing the software lifecycle (SLC) through MSP collaboration. This role demands delivering expert advice and strategic guidance throughout the SLC phases of IT solution implementation, emphasizing innovation, efficiency, and cost-effectiveness.

Responsibilities:

• Provide strategic guidance to ensure alignment with regulatory and organizational standards and oversee software lifecycle activities.
• Drive operational efficiencies by optimizing resource utilization and leveraging available capabilities through KPIs, performance metrics and SLC data reports.
• Responsible for all aspects of people leadership; setting expectations, coaching, counseling, developing, evaluating, feedback, hiring, discipline and separations. Confront and resolve employee issues in a constructive and timely manner. Responsible for overall morale of team.
• Act as the primary liaison with external partners, defining performance metrics, SLAs, quality expectations and monitoring partner performance to ensure quality of work. Lead the resolution of issues, apply root cause analysis, implement corrective actions to mitigate recurring challenges and foster a proactive risk management culture.
• Develop and utilize advanced analytics and dashboards to gain insights into trends, performance, and system health and make informed data driven decisions.
• Maintain a continuous state of audit readiness, ensuring that processes and deliverables are inspection ready.  Defend AbbVie IT practices and system qualification and validation documentation to Federal and international regulators during inspections and audits.
• Develop and compile and deliver quality metrics to management
• Champion a culture of continuous improvement by integrating lessons learned and industry advancements into ongoing processes.
• Implement and manage cloud infrastructure by ensuring compliance with applicable regulations and security protocols.
• Support the integration of CI/CD pipelines to boost business efficiency and ensure compliance. Collaborate with development and operations teams to align DevOps practices, automated testing and quality checks within CI/CD processes and reinforce compliance.

SQA Specific Responsibilities:

• Develop, implement and maintain a comprehensive SLC strategy that aligns with organizational goals, ensuring implementation of compliant high-quality Business solutions.

Qualifications

Experience:

• Bachelor's Degree with 8 years’ experience OR Master's Degree with 7 years’ experience in CSV, SQA, Investigations, and/or Auditing.
• Minimum of 1-2 years in a supervisory role.
• Strong experience managing business relations with customers and overseeing outsourced validation or SLC activities.
• Experience implementing infrastructure and strategizing qualification activities for conventional and cloud infrastructure.

Skills:

• Excellent commun