Laboratory Manager, Product Development QA

AbbVie • North Chicago, IL

3d • $109,500 - $208,500 • Hybrid

About The Position

This Hybrid role could be based in any of these AbbVie locations: North Chicago, IL Cambridge, MA, Irvine, CA, San Francisco, CA. Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release.

Requirements

• Bachelor's degree or equivalent experience is required; typically, in life sciences or engineering.
• 6-8 years of experience in function or related field, preferably with quality assurance and/or analytical sciences, or a combination thereof
• Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP manufacturing as applied to laboratory operations is preferred, as well as an understanding of Quality Assurance principles and systems.
• Strong understanding of US and international regulations for quality systems and compliance, as applicable to investigational products
• Experience in project management, coordination, and planning of complex activities
• Ability to take a collaborative and risk-based approach to problem solving
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Capable of clearly presenting and justifying quality requirements throughout all levels of management

Nice To Haves

• Master’s degree is preferred but is not required based on commensurate experience.

Responsibilities

• Support CMC teams in resolving complex technical Analytical challenges through various phases of development
• Provide leadership and daily support to the Lab QA team
• Drive continuous process improvement within Product Development QA by updating/authoring policies/processes/procedures and related documents
• Lead QA Analytical audit /inspection preparation activities and support the audits/inspections as the QA SME
• Develop, maintain, and report key quality metrics to Management
• Lead for analytical testing batch release; coordination and issue resolution
• Review and approval of excipient, drug substance and product specifications, including justification and revisions
• Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas
• Approve Laboratory investigations
• Responsible for assessing compliance to regulations and industry practice and implementing applicable process changes

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level