QA Compliance and Regulatory Director

AbbVie•Worcester, MA

1d•$160,500 - $305,000•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Lean Six Sigma Black Belt certification is preferred

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