Full 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
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
37Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
37QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines
37Lead complex global cross-functional process improvement teams.
37Provide innovative and risk-based solutions to complex technical problems.
37Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits.
37Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas.
37Provide management of clinical supply product actions and recalls.
37Support in-licensing and collaboration activities.
37Ensure 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.
37Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff.
Qualifications
37Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
37Master's degree is preferred but is not required based on commensurate experience.
378+ 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.
37Broad 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.
37Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
37Strong leadership, communication, and organizational skills.
37Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
37The 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 postingbased 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 orless than the posted range. This range may be modified in the future.
37We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
37This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company's sole and absolute discretion, consistent with applicable law.