Medical Device Quality Manager

Regulatory Jobs; Waco (TX); Sur place; USD 110 000 - 170 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

401(k) retirement plan

Long-term incentive programs

Paid time off (vacation/holidays/sick)

Résumé du poste

AbbVie seeks a Quality Assurance Operations Manager to own quality for combination products and medical devices, ensuring on-time delivery and compliance across plants and contract manufacturers.

You will lead a team of SMEs, shape global QA strategy, coordinate audits and inspections, and drive data-driven decisions to sustain product quality and regulatory readiness.

Qualifications

• Bachelor's degree in Life Science or related field; graduate degree preferred.
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, or related.
• Strong analytical, problem-solving, and multi-tasking abilities.
• Experience with third-party contract manufacturers a plus.

Responsabilités

• Own quality elements for combination products and medical devices to ensure on-time market support.
• Lead QA strategy and collaborate with AbbVie's internal plants and suppliers.
• Make key decisions on quality, compliance and regulatory conformance.
• Manage SMEs and project activities to deliver on-time quality results.
• Coordinate audits, due diligence, and inspection readiness with external manufacturers.
• Drive root-cause investigations and CAPA in response to quality events.

Connaissances

Analytical thinking

Problem-solving

Interpersonal skills

Project management

Regulatory knowledge

Formation

Bachelor's Degree in Life Science or related technical field

Graduate degree desirable

Outils

Quality management systems (QMS)

Description du poste

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, visit www.abbvie.com.

Role Overview

Responsible for quality of assigned combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Primary products include breast implants, ocular implants, consumer eyecare products, dermal fillers, infusion pumps and enteral tubing. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Collaborates to develop the appropriate regulatory strategies for product brands in concert with Regulatory Affairs.

Responsibilities

• Ensures delivery of quality elements needed to facilitate on-market support for the combination products and medical devices.
• Supports Global Product Quality Assurance strategy and implements agreed strategy to support the products at AbbVie plants.
• Makes key decisions on product quality, compliance and regulatory conformance issues for medical devices and combination products and ensures risk-based elevations to AbbVie leadership.
• Leads the collection, verification and improvement of Quality metrics for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local/global project implementation.
• Leads a team of SMEs and provides oversight for project activities and team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers, on-market support and organization optimization.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Communicates and negotiates with external companies' quality organizations to maintain a consistent level of quality and minimize compliance risks while balancing cost. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interfaces with AbbVie's audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Participates in and leads product quality investigations to identify root cause and implement corrective actions. Coordinates activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
• Collaborates with internal and external partners in providing feedback on product quality for management reviews with assigned contract manufacturers that identify and address quality, operational, and organizational issues.

Qualifications

• Bachelor's Degree in relevant Life Science or other technical field required. Graduate degree desired. Technical or analytical background required for problem resolution with technical, quality, product and/or engineering related issues.
• Minimum of 7+ years combined experience in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Ability to operate in an environment requiring a high degree of urgency, with strong analytical and problem-solving skills, positive interpersonal skills, and ability to manage multiple complex tasks simultaneously.
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• Capable of long-term strategy development and short-term crisis management, and of overcoming differing cultural and language obstacles to satisfy Corporate, Divisional, regional, and local objectives.
• Experience working the requirements for third party external manufacturing.

Compensation & Benefits

• 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 long-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.