Senior Manager, Product Development Quality Assurance (CMC Product Lead) in Irvine

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.

Job Description: 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. The Senior Manager, Clinical Product Supply is primarily responsible for providing direction and quality oversight of the supply chain, including manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus‑building across AbbVie R&D functions and external partners.

Responsibilities:

• Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
• 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/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 the various R&D Directors and VP as well as external customers and mentor staff.

Qualifications:

• Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience). Master’s degree is preferred but is not required based on commensurate experience.
• 8+ years 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.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide – global requirements for GMP (D, EU, US) is required.
• 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.
• 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.

Additional Information: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

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.