Senior Lead, SQA

Responsibilities

• Implements and maintains Quality System.
• Ensures alignment of practices and procedures with policies and regulations.
• Serve as the primary Supplier Quality representative supporting APL operations and act as the owner of the approved supplier list, including material, service, and supplier qualification, performance, and discontinuation.
• Provide leadership and direction for day-to-day supplier quality support, including incoming materials, supplier issue resolution, and oversight of supplier-related quality activities.
• Partner with APL operations, quality, procurement, planning, manufacturing, and other cross-functional teams to support uninterrupted site operations and maintain effective internal and global relationships.
• Lead supplier quality investigations, escalations, containment actions, and follow-up activities to ensure timely and effective resolution of supplier-related quality events.
• Review, assess, and disposition supplier-related quality events, complaints, deviations, nonconformances, and related quality documentation as applicable.
• Drive supplier performance monitoring through quality metrics, trend analysis, and periodic business reviews.
• Lead supplier qualification, requalification, audits, and ongoing oversight activities.
• Evaluate supplier corrective and preventive actions (CAPAs) and verify effectiveness where required.
• Escalate critical supplier quality concerns to site leadership, provide subject matter expertise, contribute to continuous improvement initiatives, and lead with minimal oversight through strong accountability, sound decision-making, and independent prioritization.

Requirements

• Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
• 6+ years experience in Manufacturing, Quality or Engineering
• Ability to problem solve and utilize analytical skills
• Knowledge of Quality/Compliance management, Regulations and Standards
• Strong leadership skills with the ability to operate independently and with minimal oversight.
• Demonstrated experience in supplier quality, auditing, QA, or a related quality function.
• Ability to influence cross-functional stakeholders and drive resolution of complex quality issues.
• Advanced understanding of quality systems, supplier oversight, and regulatory expectations.
• Travel (5-15%)
• Excellent verbal and written communication in both English and Spanish.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• 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:
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Benefits

Additional Information

Purpose The Senior Lead, Supplier Quality Assurance serves as the primary supplier quality representative supporting APL operations and is the Supplier Quality point of contact for the site. This position is responsible for ensuring supplier quality systems, processes, and supplier-related activities align with site requirements, regulatory expectations, and AbbVie quality standards. The Senior Lead is expected to exercise strong independent judgment, lead supplier quality initiatives, and proactively drive issue resolution, risk mitigation, and continuous improvement in support of site operations.

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