Company Description
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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
This Hybrid role could be based in any of these AbbVie locations: North Chicago, IL Cambridge, MA, Irvine, CA, San Francisco, CA
Purpose:
Primarily responsible for leading Product Development QA from an analytical perspective in
support of clinical supply release.
עיקרי התפקיד
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
דרישות
Bachelor's degree or equivalent experience is required; typically, in life sciences or
engineering. Master’s degree is preferred but is not required based on commensurate
experience.
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
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 thisposting 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 long-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 anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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: