Regional QA Systems 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.

I chose AbbVie
I chose Innovation
I chose a Great Place to Work

AbbVie employees work every single day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people and, when we find them, we make it our business to treat them well.

We are currently sourcing an experienced Regional QA Systems Lead to join our high performing quality team, reporting to our Vice President Quality Assurance, EU Region . In this role, you will optimise and improve Quality Systems (QS) performance within and across Regional Operations activities.

Key Responsibilities: 
• Drive critical Quality projects across multiple sites across various countries; ensure subsystems are connected and cross-system dependencies are optimized to deliver measurable compliance performance improvements.
Developing, aligning and implementing key regional QS processes and procedures, through leading the Production & Process Controls (PPC) Centre of Excellence (COE)
• Define clear governance rules to remove QS redundancy and drive global alignment of the Abbvie Quality System.
• Collaborate with partners (QA, Manufacturing, Engineering, Supply Chain etc.) in global and regional roles to drive broader network efficiency, effectiveness and alignment.
• Develop and drive Regional specific QA focused teams to deliver measurable improvement initiatives. Develop policies, processes and procedures that harmonize the quality system across the network;
• Facilitate the maintenance and execution of Regional QA Strategy and track progress against.
• Define and implement a Regional QA project management & quality planning governance to ensure clear communication of milestones and progress of Regional projects.
• Establish and maintain Quality System communications and branding that enables QA engagement and active participation by all functions across regional sites supporting AbbVie objectives, activities, and outcomes.
• Create and maintain robust linkage between QA Systems and Regulatory Intelligence/Knowledge Management to maintain the highest standards of compliance with cGMP.
• Lead the collection, verification and improvement of Quality metrics used for management review in partnership with all stakeholders to develop a clear picture of overall compliance state and linking this to local / global project implementation.
• Act as deputy for Regional Vice President QA at Product Quality (Global) Management Review
• Coordinate and actively manage relationships & agreements with Third Party Manufacturers/Customers appropriate to the Region

Qualifications

Education & Experience:
• You will have a relevant 3rd level degree & ideally MSc or PhD
• Proven knowledge and experience within the Quality organisation with experience working within & leading key COE (Centre of Excellence) projects
• Proven communicator of both tactical and strategic programs.
• Strong manufacturing/plant experience ideally stemming from within Regional experience.
• Successful track record of delivering results in complex projects and programs; proven leader of direct reports as well as of matrix teams.
• Experience working and delivering results across multiple sites/geographies.
Preferred experiences: change management, AbbVie Operations, financial planning processes.
• Ability to travel up to 35% within and across Regions, as required.

So, are you ready now to be part of that high performing and ambitious Quality team? 

It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. 

Travel
Yes, 25 % 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.