Associate Director, Quality Control (bulk & intermediate biopharmaceuticals manufacturing, immunology, oncology, & other therapeutic use)

Company Description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Key Responsibilities

• Manage QC laboratory including setting of vision & strategy, develop & manage operating budgets, management of large group of technical employees, project management, & unit operational management to support overall business operations.
• Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs & established timeline.
• Serve as an expert in technical/functional areas.
• Create & review quality system documents including test procedure, validation & technical protocols & reports, lab investigations, manufacturing records & quality control data.
• Establish & execute plans  & commitments consistent to Development, Manufacturing, Customers & Business needs.

Qualifications

Education & Experience

Must have a Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering & 5 years of management exp in QC.

Of experience required, must have at least 5 years of experience:

1. managing a team of at least 10 QC analysts;

1. performing biopharmaceutical testing within the biologics industry;

1. using Quality policies,  cGMP & other regulatory requirements; &

1. managing QC clinical & commercial projects by collaborating across a multifunctional team including contributors in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems & Regulatory Affairs.

Of experience required, must have at least 3 years of experience using statistical q