Medical Device Quality Manager

AbbVie; Waco (TX); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbV ie seeks a senior professional to lead Quality Assurance Operations Management, overseeing regulatory conformance and product quality for devices and combination products. Responsibilities include strategic QA planning, cross-functional leadership, and driving corrective actions across manufacturing sites and contract manufacturers.

You will coordinate with regulatory teams, internal auditors and suppliers to ensure timely, compliant product transfers and on-market support.

Qualifications

• Bachelor's degree in life science or related field; graduate degree preferred.
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Ability to manage multiple complex tasks with urgency and strong problem solving.

Responsibilities

• Ensure delivery of quality elements to facilitate on-market support for products.
• Support Global Product Quality Assurance strategy at AbbVie plants.
• Make key decisions on product quality, compliance and regulatory conformance.
• Lead collection, verification and improvement of Quality metrics for management reviews.
• Lead a team of SMEs for on-time quality deliverables and product transfers.
• Participate in development of global PQAS strategy for device and combination products.
• Negotiate with external quality organizations to balance quality and cost.
• Interface with audit team to develop audit plans and inspection readiness.
• Lead product quality investigations and CAPA management.
• Collaborate with internal and external partners for feedback in management reviews.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Analytical Skills

Problem Solving

Cross-functional

Education

Bachelor’s Degree in Life Science

Graduate degree preferred

Job description

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.

Company Description

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.

Job Description

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.

• 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 an oversight for project activities and the 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 organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. 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 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 required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 7+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
• A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
• Experience working the requirements for third party external manufacturing.

Additional Information

• 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 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