Quality Assurance Manager

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Quality Assurance Manager is responsible for providing quality assurance support for some or all of the following manufacturing processes:pharmaceutical products, medical devices, cosmetics,combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management and CAPA.This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates.This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

• Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff

• Directs the development of Quality policies that meet both regulatory and company requirements.

• Maintains expertise on various regulations (FDA, EMA, ICH, etc.)

• Provides compliance leadership to the manufacturing site.

• Provides direct interface with FDA and other regulatory agencies and customers during inspections.

• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.

• Review and approve deviation investigations, driving reduction in quality events through robust CAPA

• Compiles, analyzes and communicates significant quality or compliance metrics to senior management..

• Establish programs to promote quality awareness and compliance

Qualifications

• Bachelors Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.

• 8+ yearsexperience in quality assurance, quality oversight or relevant experience.

• Leadership of technical professionals and in leading cross-functional teams.

• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.

• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical,biological or device related products.

• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.

• Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.

• Strong oral (with all levels of management) and written communication skills needed.

• Excellent interpersonal skills a plus.

• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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