Laboratory Manager, Product Development QA

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.

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

Qualifications

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:

https://www.abbvie.com/join-us/reasonable-accommodations.html