AbbVie

Senior Manager, External Partners Oversight

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

Qualifications

  • Bachelor's Degree in a technical field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent experience (8+ years) in medical device or combination product industries.
  • Thorough understanding of international regulatory standards and GxP (GMP, GLP, GCP, GDP, GCLP) is preferred.
  • Technical background with knowledge of supplier oversight relevant to regulatory compliance.
  • Experience with quality management systems that support product development and regulatory standards.
  • Strong communication and interpersonal skills, demonstrating leadership and decision-making capabilities.
  • Proven ability to work collaboratively across functional teams and effectively persuade stakeholders.
  • Preferred experience in Quality Assurance/Regulatory Affairs, compliance auditing, or laboratory roles.

Responsibilities

  • Assess compliance with regulations through supplier oversight, focusing on early detection and prevention of issues.
  • Interpret and apply governmental regulations, guidelines, and policies related to supplier quality.
  • Manage the lifecycle of Quality Agreements and conduct evaluations to ensure compliance.
  • Act as a GXP expert within R&D, guiding teams toward compliant practices.
  • Collaborate with R&D to resolve supplier quality issues and prioritize project activities.
  • Lead or participate in complex, cross-functional projects and strategic initiatives for compliance improvement.
  • Analyze and report metrics related to External Partners Quality for better oversight.

Benefits

  • Comprehensive benefits package including medical, dental, and vision insurance.
  • Paid time off for vacation, holidays, and sick leave.
  • Participation eligibility in long-term incentive programs.
  • 401(k) retirement plan for eligible employees.
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.

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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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