Manager, Quality Control

Qc Validation Manager

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

Job Description

Purpose

The QC Validation Manager provides leadership and direction to the Quality Control organization pertaining to new product introduction of clinical and commercial projects. Expectations that the QC Validation Manager will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities

• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Attends, coordinates and presents at internal and external teleconferences pertaining to new product introductions
• Responsible for coordinating cross-functional activities to ensure validation timelines stay on target.
• Leads and influences peers and colleagues within the scope of their work
• Leads method validation activities for incoming projects (both internal and external), including but not limited to protocol creation and execution, validation data tabulation and review; validation summary report creation and review
• Support method transfer activities to other sites, including but not limited to tech transfer memo creation and execution, transfer data tabulation and review; method transfer summary memo creation and review
• Assist with regulatory filings and audits as required
• Write and revise SOP's in support of the Quality Control organization
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs

Qualifications

• Bachelor's Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 8+ years of experience in Quality Control
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication Skills, both oral and written

Additional Information

• 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 this posting 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 short-term incentive programs.
• 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 and until 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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