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 managementChampion a culture of continuous improvement by integrating lessons learned and industry advancements into ongoing processes.

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 communication skills and able to deal constructively with conflict.Proven ability to leverage data analytics for operational insights and strategic decisions.Demonstrated leadership in managing cross-functional teams and influencing stakeholders.Deep understanding of risk-based validation approaches.Data driven decision making that could impact cross-functional organizations.Budgeting, recovery, demand forecast, resource scaling.Advanced understanding of CSA principles, data integrity, and modern validation techniques.

Certifications (Preferred): ASQ Certified Quality Auditor, PMP, Six Sigma, or equivalent project management certifications.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

This job is eligible to participate in our short-term incentive programs. ​

This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html