QA Compliance and Regulatory Director

Regulatory Jobs; Worcester (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking a senior leader to oversee Compliance and Regulatory activities at the site Quality Operations level, guiding a team to ensure inspection readiness, client audits, and continuous improvement aligned with cGMP and global standards.

The role requires 15+ years in GMP/pharma/biologics manufacturing and 5+ years of direct leadership. Strong strategy, negotiation, and communication skills are essential for success in AbbVie's culture.

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.
• 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

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

Skills

Leadership

Regulatory leadership

Project management

Communication skills

Education

Bachelor’s degree in Engineering/ Chemistry/ Microbiology or Science related field

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

www.abbvie.com

. Follow @abbvie on

LinkedIn,

Facebook

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Instagram

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X

and

YouTube.

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

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