AbbVie

Associate Director, QA

AbbVie • $130K — $155K *
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 science or healthcare profession.
  • 7+ years in pharmaceutical industry or regulatory authority.
  • In-depth understanding of quality systems and auditing standards.
  • Comprehensive knowledge of global clinical regulations and quality management principles.
  • Strong communication, negotiation, and influencing abilities.
  • Robust analytical skills for managing complex issues.
  • Proven leadership experience in cross-functional teams.

Responsibilities

  • Lead and develop a high-performing Clinical Audit team across the Americas.
  • Contribute to the global Clinical Audit strategy at the regional level.
  • Execute complex audits and address compliance issues with auditees.
  • Develop innovative quality strategies with business partners for compliance solutions.
  • Drive continuous improvement of quality and clinical systems for regulatory compliance.
  • Assess processes supporting clinical development for quality assurance.
  • Facilitate educational initiatives on quality guidelines and compliance regulations.

Benefits

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

* This role could be based in any of our hub locations (North Chicago, IL/Cambridge, MA/Worcester, MA/Florham, NJ/Irvine, CA/San Francisco, CA) in US

Purpose:

As the Head of the Americas Clinical Quality Audit team, leads a high performing team to deliver on the Clinical Audit strategy and assure the quality and compliance of AbbVie clinical trials and studies in the region.
  • Assures quality and compliance in a regulated environment including AbbVie policies and procedures, country specific requirements, and other applicable standards and worldwide regulations.
  • Contributes to the strategic direction of the Clinical Audit Team, ensuring alignment with RDQA policies and procedures.
  • Advances the AbbVie Quality System through robust collaboration with business partners and other GxP RDQA functions and implementation of systems and processes required to support global quality assurance requirements.
  • Builds and leads high performing teams by creating an inclusive environment, focusing on people development, setting clear expectations, engages team members with clear vision on strategy and implementation. Accountable to employees to coach for success in performance.

Responsibilities:
  • Leads and develops a team of Clinical Auditors, based in the Americas, in the development and execution of all clinical audit types. Build a strategic, high-performing team that operates cross functionally to build-in quality to AbbVie processes from the outset.
  • As part of the Clinical Audit Leadership Team, contributes to the development of the global Clinical Audit strategy while driving this at an Americas level.
  • Provides leadership and strategic insight to the risk-based clinical audit program, execute more complex audits and work with auditees to resolve any non-compliance(s) identified.
  • Leads and delivers innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.
  • Drives development/continuous improvement of necessary quality and clinical systems by leading and/or supporting implementation of initiatives to assure compliance to regulations and corporate policies.
  • Analyses and evaluates processes that support clinical development in order to assure quality and compliance.
  • Drives for results for self and staff by providing clear direction, establishing stretch goals/assignments and is able to communicate expectations and objectives in a clear and well-planned manner. Maintains two-way dialogue with others related to work assignments and results; brings out the best in people.
  • Provides expert advice and support on clinical regulations, guidance and expectations to RDQA and business colleagues.
  • Provide strategic input to the inspection support model and actively support GCP inspections onsite or remotely if needed
  • Promotes continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.


Qualifications

  • Bachelor's degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
  • 7+ years of experience in the pharmaceutical industry in the fields of clinical development, clinical trials regulatory affairs and/or quality assurance supporting those areas, or with a regulatory authority.
  • Detailed knowledge of quality systems and auditing standards.
  • Extensive knowledge of worldwide clinical regulatory requirements and industry best practices, quality management principles, including global and regional regulations and internationally recognized standards (e.g. ICH, ISO).
  • Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment.
  • Ability to manage complex issues and distil information. Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.
  • Significant experience leading cross-functional and multi-location teams through complex projects with demonstrated flexibility to adapt to changing assignments and ability to effectively prioritize.
  • Ability to think strategically and communicate effectively with colleagues at all levels, including senior management.
  • Well-developed leadership competencies to deliver team objectives and projects.
  • Willingness and ability to perform domestic and international travel


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 thisposting 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 anduntil 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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