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Quality Systems Support Manager (Remote) - job 3 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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Average salary estimate

$115000 / YEARLY (est.)
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$100000K
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What You Should Know About Quality Systems Support Manager (Remote), AbbVie

At AbbVie, we are on a mission to innovate and deliver groundbreaking medicines that tackle serious health challenges, and we are excited to announce an opening for a Quality Systems Support Manager. This remote position plays a crucial role in overseeing the implementation and support of our quality systems. As the Manager, you will lead a dedicated team responsible for managing quality assurance processes, ensuring compliance across all laboratory enterprise systems. You'll be tasked with developing strategies for implementing new IT systems, maintaining operational budgets for system enhancements, and acting as a key liaison during inspections and audits. Collaborating with digital system leads globally, you'll help ensure alignment with our data governance models and master data standards, all while leveraging the latest AI tools and data automation technologies. With a focus on creating user-friendly systems, you'll drive efficient laboratory workflows that contribute to AbbVie's overarching goal of impacting lives positively. Your expertise in quality systems, along with 10+ years of experience in regulated environments, will enable you to succeed in this high-impact role. If you have a Bachelor’s degree in Science, Business, or Engineering, and a passion for compliance and quality, we invite you to explore this incredible opportunity with us at AbbVie.

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

As a Quality Systems Support Manager at AbbVie, you will be primarily responsible for implementing and supporting quality systems within the organization. This includes leading a team of QA System Specialists, overseeing the integration and management of laboratory enterprise systems, and ensuring compliance with regulatory standards. Additionally, you will manage change management processes and maintain communication between global quality teams and labs. Your role will involve strategic planning for system enhancements, making sure our systems align with the company's quality assurance objectives.

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What qualifications are needed to apply for the Quality Systems Support Manager position at AbbVie?

To be eligible for the Quality Systems Support Manager role at AbbVie, candidates must possess a Bachelor's Degree in Science, Business, or Engineering, or equivalent work experience. A minimum of 10 years of experience in quality systems or a similar regulated environment is also required. Candidates should have strong compliance and QA experience, as well as a thorough understanding of quality system development and implementation. Proven leadership skills and the ability to manage teams effectively will be essential in this position.

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How does the Quality Systems Support Manager contribute to AbbVie’s mission?

The Quality Systems Support Manager plays a vital role in AbbVie's mission to discover and deliver innovative medicines by ensuring that the quality systems in place adhere to the highest standards of compliance and efficiency. By managing quality assurance processes and collaborating with various stakeholders, this position helps maintain the integrity of laboratory operations. The manager’s efforts in implementing user-friendly systems and processes directly impact the speed and accuracy of research and development within the company, ultimately enhancing patient care.

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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 remote, allowing for flexibility in managing teams across different locations. Collaboration is key, as you will be working closely with laboratory teams, digital system leads, and global quality assurance personnel. The culture at AbbVie values innovation and integrity, fostering a collaborative atmosphere where employees can share insights and drive change together. As part of a larger mission to improve patient lives, you will find meaning and purpose in your work.

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What technologies are utilized by a Quality Systems Support Manager at AbbVie?

In the role of Quality Systems Support Manager at AbbVie, you will utilize a variety of advanced technologies to ensure the effective management of quality systems. This includes leveraging AI supporting tools and data automation technologies to enhance workflows and efficiency in laboratory operations. You will also be involved in the implementation of new technologies that support quality control operations, ensuring that they align with regulatory expectations and meet the needs of the organization.

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

When answering this question, focus on your past roles in quality assurance and the specific systems you have worked with. Highlight your accomplishments in ensuring compliance, managing audits, or leading projects related to quality systems. Providing examples of challenges faced and how you overcame them will demonstrate your problem-solving abilities.

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How do you manage project timelines and deliverables in your current role?

Discuss your project management techniques, such as using project management software or agile methodologies. Give examples of how you prioritize tasks, communicate with team members, and ensure accountability. Demonstrating an organized approach and the ability to adapt will show your capability in managing timelines effectively.

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What strategies do you use to maintain compliance during system implementation?

Explain your process for ensuring compliance during system implementations, emphasizing your understanding of regulatory requirements and standards. You might mention developing detailed plans, conducting risk assessments, and regular communication with stakeholders to align expectations and compliance needs.

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How do you ensure your team is trained and up-to-date with changing quality standards?

Share your methods for training and development, such as implementing regular training sessions, workshops, and providing access to resources for continuous learning. Talk about how you encourage team engagement and how you assess their understanding of any changes in quality standards.

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Can you discuss a successful project you led in the area of quality systems?

Provide a specific example of a project you managed, outlining the goals, challenges, and outcomes. Describe your role in leading the project, how you motivated your team, and the ultimate impact on the organization. Focus on measurable results to quantify your success.

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How do you approach data governance within quality systems?

Detail your understanding of data governance and its importance in quality systems. Discuss your experience with developing data governance models and ensuring compliance with global standards. Provide examples of how you've implemented changes in data management processes to enhance quality.

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What are your thoughts on leveraging AI in quality systems?

Share your insights on the role of AI in improving efficiency and quality in laboratory settings. Discuss your openness to integrating new technologies and your prior experience in adopting AI-supported tools in your work. Emphasize how they can streamline processes and improve compliance monitoring.

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How do you handle conflicts among team members during projects?

Discuss your conflict resolution techniques, such as open communication, active listening, and facilitating discussions. Share an example of a past conflict and how you helped resolve it, focusing on how you maintained team cohesion and focus on project goals.

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What role does communication play in your effectiveness as a Quality Systems Support Manager?

Highlight the importance of communication in fostering collaboration and transparency in your team. Discuss how you ensure effective communication across all levels and how you tailor your messages to different audiences, ensuring key stakeholders are always informed.

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Detail your experience in auditing and inspections in relation to quality systems.

Explain your auditing experience and the types of inspections you have been involved with, emphasizing your ability to prepare your team and the organization for regulatory visits. Share specific successes in passing audits or inspections and the strategies you applied to overcome challenges.

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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 22, 2025

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