Senior Manager, Product Development Quality Assurance

Summary

Join AbbVie and ensure the timely release of GMP clinical supplies by providing quality oversight of the supply chain. As a Senior Manager in interdisciplinary product development teams, you will identify and prevent pipeline risks, driving consensus across AbbVie R&D and external partners. You will act as the QA representative, providing program oversight, leading process improvement teams, and offering innovative solutions to complex technical problems. This role involves supporting regulatory inspections, writing exception reports, managing clinical supply actions, onboarding new assets, and ensuring quality agreements with third-party manufacturers. The position requires strong leadership, communication, and collaboration skills and can be remote within the US. AbbVie offers a comprehensive benefits package.

Requirements

• Bachelors in life sciences (biology, chemistry, or engineering) and/or equivalent experience
• Minimum 8+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree
• A broad understanding of pharmaceutical manufacturing processes (chemical and biological) and analytical sciences
• Strong knowledge of global GMP requirements (EU, US, etc.) and international pharmaceutical law
• Strong leadership, communication, and organizational skills
• Must be able to provide and defend the quality position and effectively solve complex technical and quality issues
• Must have a team-oriented work style and strong collaboration skills

Responsibilities

• QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines
• Provide program oversight for the RDQA QA organization; includes timely communications on program strategies, issue and risk management
• Lead complex global cross-functional process improvement teams
• Provide innovative and risk-based solutions to complex technical problems
• Support the preparation of regulatory inspections and internal audits and represent Quality in inspections and audits
• Write/ review/ approve exception reports, including high impact and complex investigations impacting multi-functional areas
• Provide management of clinical supply product actions and stock recovery
• Conduct the onboarding of new assets
• Perform due diligence of potential assets
• Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers
• Interact with and influence decision making at the senior leadership level as well as with external customers

Preferred Qualifications

• Master’s degree is preferred but is not required based on commensurate experience
• Experience applicable to investigational products is preferred
• Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs