Manager, Quality Systems

This role is critical to turning strategy into action, helping drive business goals, regulatory compliance, and continuous improvement. We’re looking for a motivated, detail-oriented professional to join our team and lead the preparation and approval of key quality documents, including Annual/Periodic Quality Reviews, Quality Agreements, and technical reports and memos. In this role, you will serve as the site lead for center of excellence teams and partner cross-functionally with Quality Control, Product Quality Assurance, PDST, Validation, and Compliance to drive document alignment and approvals. You will also work directly with third-party clients, suppliers, and other network sites to ensure timely document coordination and compliance. This position ensures product, process, and system-related quality documents meet corporate and regulatory standards. The ideal candidate thrives in a fast-paced environment, communicates effectively across teams, and brings a strong eye for detail and quality.

Responsibilities:

· Implement and maintain the effectiveness of the quality system, ensuring alignment with corporate policies, processes, and procedures.

· Design and optimize quality systems, procedures, and processes with cross-functional teams for compliance and efficiency.

· Lead project teams in planning, preparation, review, and approval of quality documentation.

· Develop, author, review, and maintain Quality Agreements with clients, suppliers, and laboratories to ensure clear expectations and regulatory compliance.

· Lead the process of authoring Periodic Quality Reviews to evaluate process performance and identify improvements.

· Participate as the site representative for Quality Agreement and Periodic Quality Review global Center of Excellence teams.

· Review and approve technical reports and memos for accuracy, completeness, and compliance with corporate and regulatory requirements.

· Ensure proper integration and support of quality regulations.

· Engage with internal and external partners to develop best practices in quality systems and procedures.

· Assess compliance to processes and regulations, identify gaps, and drive improvements within the quality system.

· Exhibit exceptional attention to detail and a strong drive for improvement throughout all responsibilities.

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills a plus.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

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 postingbased 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 orless 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. ​

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 paidand 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. 

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