Global C&Q Lead

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 Statement:

 

Responsible for setting directions, providing guidance and managing the global commissioning and qualification (C&Q) program.  Collaborate with the manufacturing site leadership, Corporate Quality and manufacturing teams to drive optimum and standardized C&Q approach across the global manufacturing network.  Lead and provide directions and validation strategy for key capital projects and paperless C&Q initiative rollout.  Benchmark with other bio-pharma companies to continue to enhance the overall C&Q program for achieving optimal program outcome.

 

Major Responsibilities:

 

• Manage C&Q and GMP coordinator contract staff
• Set Vision and Strategy for the corporation C&Q program
• Implement corporate C&Q strategies
• Identify and implement continuous improvement ideas to enhance the program
• Assist in development and plan for C&Q budget/estimates and other financial planning
• Provide leadership and oversight on key capital projects C&Q, focusing on Americas region
• Provide leadership for development, implementation and life cycle management of all relevant standards, procedures, practices and COP for C&Q
• Lead and drive paperless C&Q initiative including LRP deployment plan
• Provide program training and governance across global network
• Align engineering best practices with quality policies by partnering with Quality leadership
• Regularly interact with manufacturing & engineering leadership for priorities and support needs
• Lead engineering COP on C&Q

Qualifications

Qualifications:

 

• B.S degree in Chemical, Mechanical or Electrical Engineering
• Minimum 10 years of experience in Pharmaceutical/bio-pharmaceutical industry
• Minimum 7 years of experience in leading C&Q programs, and experience with interfacing Regulatory/Quality or auditors
• Minimum 5 years of experience with supervisory, project management and budget management are required
• Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.  Skilled in the strategy development, initiation, selection, coordination and management of projects and have ability to solve unique problems.
• Knowledge of regulations and standards affecting devices, biologics and pharma products.  Strong working knowledge of ICH, ISO, US CFR and EU regulations.
• Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
• Strong interpersonal and communication skills (verbal/written)
• Strong negotiation skills

Significant Work Activities
N/A
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.