AbbVie

Senior Manager, Combination Products & Medical Devices

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

Qualifications

  • Bachelor's degree in sciences, engineering, or related technical/scientific field.
  • Minimum of 6+ years in Quality Assurance or healthcare-related field, with medical device regulation experience required.
  • In-depth knowledge of regulations governing combination products and medical devices.
  • Strong technical acumen in product development, especially in design control methodologies.
  • Demonstrated leadership abilities in quality issue discussions and decision-making.
  • Proficient in risk management processes and their practical applications.
  • Effective relationship-builder and capable of influencing teams across various functions.

Responsibilities

  • Manage design control activities in collaboration with R&D and other interrelated functions.
  • Lead global process improvement teams to enhance quality systems.
  • Ensure compliance with device, drug, and biologics regulations in product development.
  • Perform design control activities, mentoring and guiding product team members throughout the design process.
  • Oversee design change control and conduct impact analysis on product safety and efficacy.
  • Collaborate with cross-functional teams to identify and mitigate product risks.
  • Manage relationships with 3rd party suppliers and ensure compliance with regulatory standards.

Benefits

  • Comprehensive package including paid time off (vacation, holidays, sick leave).
  • Medical, dental, and vision insurance offered to eligible employees.
  • Participation in the company's long-term incentive programs is available.
Full Job Description
Job Description

Purpose:
Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.

Responsibilities:
  • Manage and oversee the interrelated function activities related to design control with R&D functions, Science and Technology, Operations QA, Supply Chain, RA and other R&D QA functions. Interact with and influence decisions of various R&D and Operations Directors and external customers.
  • Lead complex global cross-functional quality system process improvement teams.
  • 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. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. 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 of cumulative changes.
  • Risk Management: Global collaboration with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices.
  • Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assessment of supplier changes, establishment of appropriate balance between internal oversight actions and supplier controls, provide input to quality agreements, perform relationship development, supplier site visits, etc. Support supplier audits as required. Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards.
  • 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 team member in global and local product development teams for Combination Products to proactively avoid, or appropriately address quality-related issues.
  • Provide consultation & training on specific QA expertise to internal and cross-functional groups
  • Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits as SME.


Qualifications
  • Bachelor's degree is required; preferably in sciences, engineering or other technical/scientific area.
  • Minimum 6+ years of industry experience in Quality Assurance, Development or healthcare related field. Medical device regulation experience required. Combination Product and 3rd party supplier management experience preferred. Less experience considered with advanced degree.
  • Broad 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.
  • Key leadership competencies and making difficult decisions, relationship-building, influencing, fostering teamwork. Knowledge of the business and sound judgment.
  • 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.


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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