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About the Role

Primarily responsible for supporting AbbVie’s pipeline by ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. Provides direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. Identifies and prevents pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.

Responsibilities

Provide program oversight for the RDQA QA organization, including timely communications on program strategies and issue management.
Serve as the QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
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, and approve exception reports, including high impact and complex ERs impacting multi-functional areas.
Provide management of clinical supply product actions and recalls.
Support in-licensing and collaboration activities.
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 and other sites.
Interact and influence decisions of various R&D Directors and VP, as well as external customers, and mentor staff.

Requirements

Bachelors degree in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
8+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development, or other healthcare-related field.
Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide global requirements for GMP (D, EU, US).
Experience in project management and ability to manage multiple priorities.
Strong leadership, communication, and organizational skills.
Must be able to provide and defend the quality position, and effectively problem-solve complex technical and quality issues.

Skills

Quality Assurance
Production
Testing of active pharmaceutical ingredients
Drug products
Drug development
Pharmaceutical manufacturing processes
Analytical sciences
GMP
Project management
Leadership
Communication
Organizational skills
Problem-solving

Experience Level

8+ years industry experience

Education Level

Bachelors degree in life sciences (biology, chemistry, or engineering) and/or equivalent experience
Master’s degree is preferred but is not required based on commensurate experience

Salary/Compensations

USD 124500 - USD 236500 - yearly

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Eligible to participate in our short-term incentive programs

About the Company

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, X and YouTube.

Equal Opportunity

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