Associate Director, Neurotoxin NPI Product Quality

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.

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Welcome to AbbVie! 

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work. 

We are now recruiting an Associate Director, Neurotoxin NPI Product Quality for our diverse team reporting to the Director, Toxin Quality Strategy, and We are now recruiting an Associate Director, Neurotoxin NPI Product Quality for our diverse team reporting to the Director, Toxin Quality Strategy. This role can be based either on site or remotely. You will be responsible for quality of assigned products for the Neurotoxin Pipeline to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products under your remit include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. 

Are you intrigued? Do you want to learn more? 
A snapshot of your key responsibilities as Associate Director, Neurotoxin NPI Product Quality would be:

• Represent Quality during product transfer activities with direct cross-functional team members to achieve on-time quality deliverables and high customer value.


• Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to AbbVie domestic and International plants for further packaging and/or testing.


• Act as the primary quality representative for the global supply chain pertaining to manufacturing business relationships and build and maintain relationships with IME Operations, Supplier Quality Management, Commercial QA, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic initiatives.


• Develops Global Product Quality Assurance strategies and implements agreed strategies to support relevant products produced at AbbVie plants. 


• Reviews, approves and opens necessary Quality System Management records in a timely manner to maintain a high level of product compliance. Supports the management of exception documents and CAPA.


• Makes key decisions on product quality, compliance and regulatory conformance issues and elevates medium and high-risk events to AbbVie management.  


• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the same agreements are being fulfilled. 


• Core team member or lead of strategic NPI QA programs; including Brand Teams, New Product  Introductions, Product Transfers and Global Strategic Initiatives. 


• Influences the decision-making process to ensure quality requirements are included when improvement initiatives take place.



 
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So, what do you need to do this role? 
Education & Experience  

• Bachelor’s Degree in relevant Life Science or other technical area required.


• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.


• Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors.  


• Direct plant experience in a pharmaceutical setting with a minimum of 7 years preferred.


• Knowledge and a comprehensive understanding of some biological and/or pharmaceuticals. 


• A wide range of activities are undertaken from long term strategy development to short term crisis management.  


• The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, Regional, and local objectives to effectively manage the action plans that will resolve the issues.



 
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So, are you ready to join our 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. 
 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.