Senior Lead, SQA

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

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.
• Identify, communicate, and mitigate supplier quality risks; support change control and new product introduction activities; ensure compliance with regulatory requirements, internal procedures, and quality system expectations; and resolve issues affecting material availability, product quality, and supply continuity.
• 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.

Qualifications

• 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: ​

• 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. ​

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