QA Compliance and Regulatory Director

Allergan; Worcester (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie in Worcester, MA, seeks a senior quality leader to oversee site Quality Operations, ensuring regulatory compliance and successful inspections. You will drive continuous improvement, manage a cross-functional team, and partner with global functions to deliver compliant products.

The role requires extensive GMP/biopharma experience, Lean Six Sigma, and strong strategic leadership to support filings and risk management. This is a high-impact, leadership-focused position.

Qualifications

• 15+ years’ experience in GMP pharmaceutical/biologics/medical device manufacturing
• 5+ years of progressive people leading experience
• Lean Six Sigma Black Belt certification preferred
• Advanced knowledge of cGMPs, GXP regulatory standards
• Ability to manage multiple projects with global teams
• Strong communication and influencing skills

Responsibilities

• Oversee Compliance and Regulatory activities at site operations
• Lead a team responsible for a broad range of activities including inspections and audits
• Support CMC filing and responses and market expansion filings
• Own client quality agreements and risk management programs
• Ensure site management review program effectiveness
• Provide inspirational leadership and develop talent within the team
• Promote AbbVie culture and succession planning for Site Quality Director

Skills

Strategic leadership

Regulatory knowledge

Project management

Communication

Lean Six Sigma

Cross-functional collaboration

Change management

Education

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

Job description

Company 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, Instagram, XandYouTube.

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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html