Executive Director, Commercial Quality - United States
This position can be located in New Haven, CT or Lexington, MA
The Executive Director (ED), Commercial Quality (CQ) has overall responsibility for establishing and maintaining an appropriate and sustainable Quality Management System (QMS) and Quality Culture within Alexion’s Commercial organization. The ED, Commercial Quality is a customer facing role and is accountable for Quality oversight of Alexion’s Commercial organization including the company’s country affiliates. The ED, Commercial Quality will develop, implement and maintain all GxP activities in alignment with both business objectives and regulatory requirements within in the regions and countries of operation. The ED, Commercial Quality supports the Good Pharmacovigilance Practices (GVP) and Good Distribution Practices (GDP) related to commercial activities to ensure that they are conducted in accordance with applicable regulatory requirements, guidelines, laws, and Company's established standards and practices. The ED, Commercial Quality is a member of the Global Quality Leadership team and works in close partnership with Global Medical Affairs and Global Commercial Leadership.
The successful candidate will have strong functional grounding with both US and international experience, will have previously built and managed an internal team, will have strong leadership and influencing skills and a proven ability to drive the CQ agenda as appropriate to support the following activities:
- Lead CQ group; direct supervision of CQ employees, including recruiting, objective setting, performance management, coaching, training and development.
- Ensure that Corporate Procedures and Standards are properly deployed into the Commercial QMS and are managed accordingly.
- Develop, implement and maintain the Commercial QMS including all necessary GxPs, norms regulations and standards related to the scope of the business
- In coordination with the SVP and peers within the Global Quality organization, work to develop and implement a common platform of quality and compliance systems, tools, and procedures and standards
- Create, implement and maintain Standard Operating Procedures (SOPs) and Work Practices (WPs) for the Commercial organization in accordance with GxP guidelines and global/local regulatory requirements.
- Monitor and ensure compliance with GxPs, SOPs and Working Practices (WPs) for the Commercial organization including Alexion Global Affiliates, Alexion Commercial Business Units and third parties contracted by Alexion to perform GxP activities.
- Recommend, enforce and monitor corrective actions for all identified deviations from GxPs, SOPs, WPs.
- Coordinate all activities related to training and education on GxPs, SOPs and WPs.
- Responsible for supporting the preparation and conduct of regulatory authority inspections as necessary.
- Travel of up to 30% may be required.
- 10 to 20 years' of hands-on global/ international CQ experience in pharmaceutical/ biotech industry. Thorough knowledge of applicable global regulatory and GxP requirements required.
Bachelor’s degree is required. An advanced degree is preferred. Must have minimum 10 years’ experience progressive people management experience.
New Haven, CT, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer