AbbVie

Manager, Design Quality Late-Stage Development

AbbVie • $120K — $150K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering, Life Science, or related field required.
  • 7+ years of combined experience, with 5 years in Operations Quality Assurance.
  • Comprehensive understanding of combination products and medical devices.
  • Leadership skills with a proven track record on Quality issues.
  • Sound technical knowledge of product development and design control.
  • Familiarity with risk management methodologies.
  • Strong analytical and problem-solving skills.

Responsibilities

  • Serve as the primary quality lead for project activities to ensure on-time quality deliverables.
  • Ensure compliance with device, drug, and biologics regulations.
  • Perform design control activities and mentor product team members.
  • Assess design control documentation and manage design change control requirements.
  • Identify process gaps and lead cross-functional teams for solutions.
  • Support regulatory inspections and represent QA as a subject matter expert.
  • Participate in developing global Product Quality Assurance strategy.

Benefits

  • Comprehensive benefits package including paid time off and medical/dental/vision insurance.
  • 401(k) plan for eligible employees.
  • Participation in long-term incentive programs.
Full Job Description
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 combination products and medical devices. 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.

Responsibilities:
  • Serves as the primary quality lead 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 and organization optimization.
  • Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
  • Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. Participate in design reviews. Ensure interfaces to drug development where appropriate.
  • Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Analyze and justify the impact on cumulative changes.
  • Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
  • Guide project development as a team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations.
  • Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
  • 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.
  • Participates on New Product teams to bring combination products and medical devices through the Design Control process to deliver on-time product launches. Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing.
  • Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues for sterile and unsterile devices and elevates medium and high-risk events to AbbVie management.
  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
  • Maintains relationships and open communication with suppliers, contract manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
  • 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.


Qualifications
  • Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required.
  • 7+ years of total combined experience. At least 5 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting.
  • Knowledge and a comprehensive understanding of combination products, medical devices and manufacturing processes. Experience with root cause investigations, CAPA, statistics and data analytics is a plus.
  • Understanding of regulations and standards affecting combination products and medical devices required. Must have leadership skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions.
  • Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
  • Well-versed in risk management methodologies and their application.
  • Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
  • Work independently and in a global team environment, and with all levels of personnel within the organization.
  • 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.


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.

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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

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