Director, Quality Control Labs

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Purpose:

The Director of the Quality Control Labs is responsible for managing analytical, microbial, stability and the reference standard quality control operations consisting of multiple disciplines. This includes establishment of processes and procedures, goals that are in-line with business operations, setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to ensure our Quality Control (QC) operations align with business needs. Functions as the technical consultant to business operations to conceive, design, conduct, and lead advanced independent scientific research activities per strategic business needs. This role will have responsibility for stability and reference standard operations of the lab.

Responsibilities:

• Manages QC business units including setting of vision and strategy, develop and manage operating budgets, management of large group of technical employees, project management, and unit operational management to support overall business operations.
• Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas.
• Direct management of lab operations and to provide product quality system leadership to business operations.
• Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
• Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external customer's needs.
• Applies extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
• Applies advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
• Provides leadership in Product Quality Control Procedure and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance.
• Establishes and enforces product quality system procedure for business operations. Interface with multi-disciplinary functional areas including, development, operations, quality, compliance, and regulatory.

Qualifications

Qualifications:

• Bachelor's degree with 15+ years of Quality and/or Regulatory experience
• Prior experience managing a QC laboratory or other technical/scientific group
• Strong people leadership skills
• Solid understanding of financials and budgetary management experience
• Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.
• Shows broad understanding of the issues relevant to the technical/science and business.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.