AbbVie

Medical Device Quality Manager

AbbVie • $108K — $130K *
Waco, TX 76706In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Life Science or related field; graduate degree preferred.
  • 7+ years of experience in Quality Assurance Operations Management, Regulatory, or Technical Support.
  • Strong analytical and problem-solving skills with the ability to manage multiple complex tasks.
  • Background in quality assurance/control, manufacturing, laboratory, or regulatory processes required.
  • Experience with third-party external manufacturing requirements.

Responsibilities

  • Ensure quality elements for on-market support of combination products and medical devices.
  • Support and implement Global Product Quality Assurance strategy at AbbVie plants.
  • Make key decisions on product quality and compliance issues, escalating risks to leadership.
  • Lead collection and improvement of Quality metrics for management review.
  • Oversee project activities and team members to achieve quality deliverables and customer value.
  • Develop and implement global Product Quality Assurance strategy for AbbVie and contract manufacturing.
  • Communicate with external quality organizations to balance compliance risks and operational costs.
  • Lead product quality investigations and coordinate corrective actions.

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
  • Eligibility for long-term incentive programs.
Full Job Description
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

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 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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at AbbVie.

Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at AbbVie

More Pharmaceuticals & Biotech Jobs

Find similar Medical Device Quality Manager jobs:

NationwideWaco, TX