Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
Associate Director, Design Quality - Late Stage Development image - Rise Careers
Job details

Associate Director, Design Quality - Late Stage Development - job 4 of 6

Company Description

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

Job Description

Purpose

Responsible for quality of assigned New Product Introduction (NPI) 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. Products include on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories.  Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships.  Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders. Acts as the primary quality representative and manages a team of product subject matter experts (SMEs).

 

Responsibilities:

  • Lead a team of Quality Professionals responsible for managing Design Control activities for NPI projects and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results.
  • Ensures delivery of all quality elements needed to facilitate new product introductions of combination products and medical devices.
  • Develops Global Product Quality Assurance strategy and implements agreed strategy to support the development of NPI projects.
  • 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 NPI projects.
  • Participates in the development of global Quality Assurance strategy for NPI projects to support development of device and combination products. 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.
  • 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

Qualifications

  • Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required. Graduate degree desired.
  • 10+ years of total combined experience.  At least 7 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting.
  • Leadership of technical professionals and experience in leading global cross-functional teams with results-orientation. Skilled in the initiation, selection, coordination and management of projects and ability to resolve unusually complex technical problems by providing solutions that are highly innovative.
  • Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products, ISO standards, US Code of Federal regulations, and the EU regulations.
  • Knowledge and a comprehensive understanding of medical devices and manufacturing processes.  Experience with root cause investigations, CAPA, statistics and data analytics is a plus.
  • 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, 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 short-term incentive programs. ​

  • 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

AbbVie Glassdoor Company Review
3.9 Glassdoor star iconGlassdoor star iconGlassdoor star icon Glassdoor star icon Glassdoor star icon
AbbVie DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of AbbVie
AbbVie CEO photo
Richard A. Gonzalez
Approve of CEO

Average salary estimate

$135000 / YEARLY (est.)
min
max
$120000K
$150000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs
Photo of the Rise User
Posted 10 days ago

Join AbbVie as a Peptide Chemist where you will lead the development of innovative therapies aimed at transforming patient lives.

Photo of the Rise User

Become a key player at AbbVie as a Senior Analyst in Finance, specializing in External & Contract Manufacturing.

Photo of the Rise User
Posted 10 days ago

Become a critical part of State Street's success as a QA Automation Engineer II, where your passion for quality will drive innovative solutions in the financial services industry.

Photo of the Rise User
Neuralink Hybrid Austin, Texas, United States
Posted 10 days ago

Become a key player at Neuralink as a Quality Assurance Manager, leading compliance efforts for groundbreaking brain interface technology.

Join Covenant Health as a Coordinator of Quality and Care Management, focused on enhancing patient care through collaboration and quality initiatives.

Photo of the Rise User
Apple Hybrid Cupertino, California, United States
Posted 23 hours ago
Inclusive & Diverse
Diversity of Opinions
Work/Life Harmony
Dare to be Different
Reward & Recognition
Empathetic
Take Risks
Growth & Learning
Transparent & Candid
Mission Driven
Passion for Exploration
Feedback Forward
Medical Insurance
Dental Insurance
Vision Insurance
Mental Health Resources
Life insurance
Disability Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Learning & Development
Paid Time-Off
Maternity Leave
Social Gatherings

Join Apple as a Tools and Automation Engineer, where you’ll play a key role in enhancing tools for video makers and storytellers.

Photo of the Rise User
Heritage Specialty Foods Hybrid Milwaukie, Oregon, United States
Posted 11 days ago

Join Heritage Specialty Foods as an Entry Level QA Technician and contribute to our mission of delivering high-quality, fresh foods.

Photo of the Rise User

Join Copperhead as an Audit and Quality Control Claims Specialist, where you will play a vital role in supporting disaster relief efforts.

Photo of the Rise User

We are looking for a driven QA/QC Manager for Process Piping to join WWPS, focusing on quality assurance in large-scale construction projects.

Photo of the Rise User

SQA Services seeks a skilled Quality Assessor to enhance operations and quality control at manufacturing sites across the USA.

Join Resultant as a Quality Assurance/Automation Engineer to drive operational efficiency by leveraging automation and data workflows.

Posted 7 days ago

Lead Stride’s quality assurance efforts as a Senior Manager, enhancing our automation frameworks and driving software excellence.

Lavendo Remote No location specified
Posted 13 days ago

A leading SaaS company in data privacy is seeking a Manual QA Tester to enhance their engineering team with your quality assurance expertise.

Elevate standards at CoreDux USA as our Quality & Continuous Improvement Manager, ensuring top-notch quality in a cutting-edge machining environment.

Join a dynamic team at Select Specialty Hospital as a Quality Coordinator, where your passion for patient care will make a lasting difference.

AbbVie’s mission is to discover and deliver innovative medicines 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: i...

3511 jobs
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 23, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
Photo of the Rise User
14 people applied to QA Specialist (Remote) at Yembo
Photo of the Rise User
Someone from OH, Cincinnati just viewed Group Facilitator - Outpatient at Discovery Behavioral Health
B
Someone from OH, Lima just viewed Head of Digital Acquisition at Booksy