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Quality Systems Support Manager (Remote) - job 2 of 4

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 XFacebookInstagramYouTubeLinkedIn and Tik Tok.

Job Description

Primarily responsible for quality systems implementation and support. This role manages activities supporting the QA System and business driven objectives. The Manager, Quality Systems Support has leadership responsibilities over all laboratory enterprise systems providing oversight to business system owners and the site digital system leads/administrators. In addition to these responsibilities the Manager, Quality Systems Support owns the business change management processes and data governance models within the enterprise systems ensuring compliance in all sites within the AbbVie enterprise.

•Manage team of 2 direct reports; QA System Specialists.
•Oversee projects for implanting new IT Systems, setting robust implementation strategies and tactical implementation plans.
•Develop long-range and capital plans to maintain and advance our enterprise systems in alignment with the overall laboratory strategic objectives.
•Maintain operating budget for capital and operating expense associated with business owned system maintenance and enhancement.
•Maintain global policies for laboratory enterprise systems ensuring compliance with regulatory expectations for software quality assurance, software development lifecycle.
•Act as the primary liaison for questions relating to enterprise laboratory systems during site regulatory and third party inspections/audits.
•Provide strategic direction and indirect oversight to digital system leads at each laboratory within the enterprise (globally), ensuring alignment with global master data standards and change management practices.
•Accountable for the maintenance of communication between sites and global quality/global BTS teams through established routine communication/collaboration forums.
•Accountable for successful implementation and sustainability of robust, user friendly, enterprise systems that drive efficient and effective execution of laboratory workflows.
•Leveraging AI supporting tools and data automation technologies
•Support implementation of new technologies
•Identify and implement new technologies for QC Operations

 

.

Qualifications

•Bachelor’s Degree in Science or Business or Engineering or equivalent work experience required
•Compliance and/or QA experience 
•Quality system development and implementation
•10+ years of experience in quality systems or business support in a regulated environment

Additional Information

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

  • 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​

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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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

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What You Should Know About Quality Systems Support Manager (Remote), AbbVie

Are you someone who thrives in an environment where quality meets innovation? At AbbVie, we're on a mission to discover and deliver groundbreaking medicines and solutions that address serious health challenges. We are currently looking for a talented Quality Systems Support Manager to join our remote team. This role is not just about managing systems; it's about transforming how we maintain quality and efficiency across our laboratory operations. As a Quality Systems Support Manager, you’ll lead a dedicated team of QA System Specialists, overseeing the implementation and enhancement of our quality systems. You'll play a crucial role in ensuring compliance with regulatory standards while acting as the primary liaison during audits and inspections. You're going to dive deep into developing strategies for implementing new IT systems and managing change, all while keeping the user experience at the forefront of your efforts. With AbbVie, you will be at the epicenter of innovation, leveraging AI and data automation technology to propel quality control operations forward. If you have a passion for quality assurance and a background in science, business, or engineering, coupled with substantial experience in regulated environments, we want to hear from you! Join us and be a part of something remarkable where you can make a real impact on lives worldwide.

Frequently Asked Questions (FAQs) for Quality Systems Support Manager (Remote) Role at AbbVie
What are the main responsibilities of a Quality Systems Support Manager at AbbVie?

As a Quality Systems Support Manager at AbbVie, your main responsibilities include managing a team of QA System Specialists, overseeing the implementation of quality systems, and ensuring compliance with regulatory expectations. You will develop long-range and capital plans in alignment with laboratory strategic objectives and act as the liaison during regulatory inspections.

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What qualifications do I need to apply for the Quality Systems Support Manager position at AbbVie?

To apply for the Quality Systems Support Manager position at AbbVie, you should possess a Bachelor’s degree in Science, Business, or Engineering, or equivalent experience. Additionally, you will need over 10 years of experience in quality systems or business support within a regulated industry, with a strong understanding of compliance and quality assurance.

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How does AbbVie support its Quality Systems Support Manager in implementing new technologies?

At AbbVie, the Quality Systems Support Manager is empowered to identify and implement new technologies to enhance quality control operations. The role leverages AI tools and data automation technologies, ensuring that the systems are user-friendly and drive efficient workflows within laboratory settings.

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What kind of team will I be managing as a Quality Systems Support Manager at AbbVie?

In the role of Quality Systems Support Manager at AbbVie, you will manage a team of two direct reports, specifically QA System Specialists. You will provide oversight and strategic direction, ensuring that the team aligns with global standards and effectively implements quality assurance practices across laboratory systems.

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What is the work environment like for a Quality Systems Support Manager at AbbVie?

The work environment for a Quality Systems Support Manager at AbbVie is dynamic and collaborative, as it operates in a remote setup. You will engage with various stakeholders and teams globally, fostering communication and teamwork to maintain high standards of quality and compliance in laboratory enterprise systems.

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Common Interview Questions for Quality Systems Support Manager (Remote)
Can you describe your experience with quality system implementation in a regulated environment?

When discussing your experience, focus on specific projects where you implemented quality systems. Mention the challenges you faced, your strategies for overcoming them, and the outcomes that resulted from your efforts. Emphasize your understanding of compliance and the importance of quality assurance.

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How do you prioritize tasks when managing multiple projects within quality assurance?

Effective prioritization is key in quality assurance roles. Explain your approach to assessing project urgency and impact on quality systems. You might discuss methodologies like the Eisenhower matrix or software tools you use to keep track of tasks while ensuring compliance and quality standards are met.

Join Rise to see the full answer
What strategies do you employ to ensure compliance during regulatory audits?

Outline your strategies for successful compliance during audits, such as pre-audit assessments, staff training, and regular internal checks. Highlight your communication skills and how you coordinate with team members to ensure everyone is prepared and aligned with compliance requirements.

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Can you give an example of a technological tool you implemented to improve quality control?

Share a specific example of a technology solution you've introduced. Discuss the tool’s purpose, how you assessed its fit for existing systems, and the improvements it brought to quality control processes. Emphasize your role in training others and ensuring smooth integration.

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How would you handle resistance to a new quality system implementation?

Addressing resistance involves clear communication and understanding concerns. Share your approach to involving stakeholders early in the process, gathering feedback, and demonstrating the benefits of the new system. Discuss how you would implement training to ease the transition.

Join Rise to see the full answer
What is your experience with managing teams in a remote setting?

Discuss your strategies for leading remote teams, including regular check-ins, establishing clear communication channels, and leveraging technology for collaboration. Share examples of how you maintain team engagement and ensure accountability in a remote work environment.

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Describe a time you had to navigate a complex regulatory issue.

Share a specific incident that highlights your analytical skills and problem-solving abilities. Detail the steps you took to address the issue, engage relevant stakeholders, and ensure compliance. Emphasize the positive outcomes that resulted from your efforts.

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How do you track and measure the effectiveness of quality systems?

Explain the key performance indicators (KPIs) you use to assess the effectiveness of quality systems. Discuss how you collect data, analyze trends, and implement necessary adjustments to enhance performance while adhering to regulatory standards.

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What initiatives have you taken to foster a culture of quality within your team?

Share specific initiatives you've led to promote a quality-focused culture, such as training programs, celebrating successes, and regular reviews of quality performance. Highlight how these initiatives have positively impacted team morale and compliance.

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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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Full-time, remote
DATE POSTED
April 23, 2025

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