Laboratory Manager, Product Development QA
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.
Responsibilities:
- 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
- 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
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.
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