Aldevron
  • 15-Mar-2018 to 30-Dec-2018 (CST)
  • Fargo, ND, USA
  • Full Time

Health, Vision, Dental, Life, Long and Short Term Disability, 401k w/match, FSA/HSA, PTO


We are seeking an exceptional leader who thrives in a fast-paced manufacturing environment to oversee all operational aspects of our Quality Assurance (QA) function.  As Director of QA, you have demonstrated leadership ability in large group and team settings.  You are able to lead and motivate your team, providing a unifying vision.You have proven problem-solving aptitude and multi-tasking skills.  You have strong collaboration and communication skills, and can interface effectively with all levels of an organization. You have a proven track record of crticital thinking, flexibility, and innovation.  

About the Role:

As Director of QA, you will be accountable to establish, maintenance, administration and continuous improvement of all aspects of cGMP Quality Operation functions (i.e., Quality Systems, Change Control, Document Control, Training, Vendor/Supplier QA, etc) through all phases of product development, commercial and life-cycle to assure compliance to all phase appropriate requirements pertaining to Good Manufacturing Practices (GMP), ICH and EMA regulations.  You will manage QA responsibilities to support the manufacturing, testing and release of finished product under FDA/EU regulations, standards and internal procedures. You will also be responsible for conducting investigations into GMP-related issues, management of the change control process, SOP preparation/revisions, GMP training programs and all other quality systems. 

About You:  

  • 10+ years of relevant experience in Quality is required, at least 3 years of that must be in a leadership capacity with direct reports
  • Experience in a variety of areas of the Quality Management Systems. 
  • Direct experience with regulatory audits, including direct interface with inspectors. 
  • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application. 
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience is preferred.  
  • Capable to manage multiple priorities and maintain adherence to timelines. 
  • Must be able to build effective working relationships with key business partners, customers, suppliers and peers. 

Education

  • Bachelor's degree in life sciences, i.e., biology, chemistry, etc. required

Who is Aldevron?

Aldevron is a leader in advancing biological science. Our custom development and manufacturing services provide scientists around the world with the essential components to accelerate research and open up their laboratories for groundbreaking science and breakthrough discoveries.

Why choose Aldevron?

We are in a landmark moment in the history of life science, and Aldevron is at the center of it. With our commitment to quality, we provide career opportunities that allow employees to grow and succeed, while helping make everybody's lives better.

Eligibility to work in the U.S. is required.

Aldevron
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