AbbVie

QA Compliance and Regulatory Director

AbbVie • $150K — $180K *
Worcester, MA 01604In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Chemistry, Microbiology or related field required
  • 15+ years in GMP pharmaceutical, biologics, or medical device manufacturing; 5+ years in a leadership role
  • Lean Six Sigma Black Belt certification preferred
  • Expertise in strategy development and project management
  • In-depth understanding of cGMPs, GXP, and relevant regulatory standards
  • Capacity for managing multiple projects with global teams
  • Strong facilitation, negotiation, and influencing skills necessary

Responsibilities

  • Oversee site operations for Compliance and Regulatory activities
  • Lead inspection readiness for regulatory and client audits
  • Implement internal self-inspection programs to ensure compliance
  • Support CMC filings and assist with market expansion
  • Manage client quality agreements and risk management programs
  • Contribute to facility support initiatives like pest control and engineering updates
  • Lead a team, promoting communication and professional development

Benefits

  • Comprehensive benefits package including paid time off, medical, dental, and vision insurance
  • 401(k) plan participation eligible for employees
  • Opportunity to engage in long-term incentive programs
Full Job Description
This role serves to provide leadership at the site Quality Operations level to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System. Quality excellence is a key strategic driver to ensure regulatory standards are understood and adhered to at the site operations level. This position holder will have responsibility for oversight of the Compliance and Regulatory activities for the site and ensure successful inspection outcomes and delivery of high quality, compliant products for the patients that we serve. Responsibilities Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team responsible for a broad range of activities:
  • Inspection readiness and execution for regulatory agencies; Audit readiness and execution for client audits
  • Lead internal self-inspection program to maintain compliance with AbbVie quality requirements and global standards
  • Support CMC filing and response to questions; provide data and support for market expansion filings
  • Ownership of client quality agreements
  • Ownership of risk management programs
  • Facility related support such as pest control, engineering updates, and non-process related systems
  • Ownership of the site management review program
  • Leading and inspiring a team of individuals, providing an exceptional employee experience through clear communication, sensible goal setting, succession planning and development planning
  • Demonstrating and Promoting AbbVie culture and Ways of Working
  • Intention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader AbbVie network
Qualifications
  • Bachelor's degree is required; preferably in Engineering, Chemistry, Microbiology or Science related field
  • 15+ years' experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5+ years of progressive people leading experience required
  • Lean Six Sigma Black Belt certification is preferred
  • Skilled in strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
  • Advanced knowledge of cGMPs, GXP, and other regulatory standards and guidelines applicable to medical device/bio/pharmaceutical industry
  • Ability to manage multiple projects and work with global cross-functional teams.
  • Experience in facilitation, negotiation, and influencing skills. Ability to drive change.
  • Strong verbal and written communication skills needed; excellent interpersonal skills required
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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