AbbVie

Senior Manager, External Partners Oversight

AbbVie • $120K — $145K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a technical or scientific area or equivalent experience (8+ years) in related industries.
  • Thorough understanding of international regulatory standards and GxP (GMP, GLP, GCP, GDP, GCLP).
  • Technical background with a strong grasp of supplier oversight.
  • Proficiency in quality/operational systems for study/product design and quality management principles.
  • Exceptional communication, leadership, and organizational skills; ability to work collaboratively across functions.
  • 8+ years of relevant experience in Quality Assurance, Regulatory Affairs, compliance/auditing, or laboratory environments.
  • Desirable accreditation from a professional body, e.g., ASQ Certified Quality Manager or Certified Quality Auditor.

Responsibilities

  • Assess compliance with regulations through supplier oversight activities to prevent issues early.
  • Interpret and apply governmental regulations and guidelines to related activities.
  • Manage the life cycle of Quality Agreements including creation and periodic reviews.
  • Act as an expert in GXP requirements within R&D.
  • Collaborate with R&D to resolve external supplier quality issues.
  • Prioritize and maintain project oversight to meet study objectives and timelines.
  • Lead complex cross-functional projects and strategic initiatives to enhance compliance.

Benefits

  • Paid time off including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance coverage.
  • 401(k) retirement plan participation for eligible employees.
  • Opportunity to participate in long-term incentive programs.
Full Job Description
Job Description

Purpose:

Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of external suppliers that provide materials and services to AbbVie.

Provides leadership, direction, and execution in compliance and quality; assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements to assure quality, effectiveness and safety of our medical device, clinical materials, and drug development suppliers.

Responsibilities:
  • Assess compliance with applicable regulations through supplier oversight activities. The strategic focus is for early detection and prevention, followed by correction of issues.
  • Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures as applicable to associated activities.
  • Manage Quality Agreement life cycle; lead the creation of the Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable.
  • Provide an active role within R&D as an expert in GXP requirements.
  • Collaborate with R&D functional areas and assist in the resolution of external supplier quality issues.
  • Prioritize activities to ensure objectives of studies/programs are met. Maintain project oversight to include awareness of project timeliness.
  • Lead or participate in technically complex and strategic cross functional projects.
  • Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
  • Achieve a difficult balance of involvement, independence, and objectivity.
  • Collect, analyze, and report metrics pertaining to External Partners Quality.
  • Consistently demonstrate AbbVie's Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.


Qualifications

  • Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to medical device or combination product related industries.
  • Thorough understanding of international regulatory standards. Understanding of GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations and standards preferred.
  • Must have a technical background and a thorough understanding of the supplier oversight.
  • Must understand a variety of quality/operational systems that support study/product design, device development and understand the principles of quality management.
  • Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment.
  • Persuasive, effective communication skills are essential with an ability to work effectively across RDQA functions, across technical areas and outside of the company.
  • 8+ years of experience in function or related fields, such as Quality Assurance/Regulatory Affairs, pharmaceutical/device/healthcare industry, compliance/auditing experience (preferred) and/or laboratory experience (preferred).
  • Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA).


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 Senior Manager, External Partners Oversight jobs:

NationwideNorth Chicago, IL