Director,RegionalQuality Assurance (Affiliates)
V.P Corporate Quality
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than40countries for the treatment of PNH, and in the United Statesand European Unionfor the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development.Furtherinformation about Alexion Pharmaceuticals, Inc. can be found at:www.alexionpharma.com.
The Director, Regional Quality Assurance (Affiliates) will be responsible for leading Affiliate Quality Managers in the implementation and execution of the Corporate Quality System at designated affiliate(s) within Alexion. The candidate will be the primary Quality contact in their designated region, and will have strong experience in GxP’s and quality systems, be a key business partner and contributing member of the Commercial leadership team and have the ability to function independently and in a matrix environment.
- In coordination withthe VP of Corporate Quality, theotherRegionalQuality Directors,QualityAssuranceandrelatedpeers within the Global Quality organization,theDirectorRegionalQuality Assurancewillwork tolead the successfulroll out and on-going compliance to Alexion’sglobalquality and compliance systems,andassociatedprocedures and standards.
- Provideleadership andresourcemanagement support to Corporate QualityandAffiliateslocated within regional area.
- Ensurethat Alexion Policies, Global Quality Standards Operating Procedures (SOPs) areimplementedin accordancewith US, EMA, other globalandlocalGXPguidelines.
- Ensure Alexion is kept fully informed of new or emerging GMP, GDPand regulatory changes in their region and assess impact of regulatory change on Corporate policies and procedures.
- Leadthe reviewand implementation ofQuality Improvement/remediation plansfor theirregional Affiliatesidentified throughQualityaudits
- Participate as a contributing member of the Regional Leadership Team to assure goals and priorities are supported within the Quality System.
- Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities. Assure sites are in a state of inspection readiness and lead support during internal and external inspections/audits. Partner with R&D and PV as required for GVP audits and inspections.
- In collaboration with the Corporate Quality organization,weigh and communicate quality and compliance risks as appropriate
- Monitor compliance to regulations and Alexion’s proceduresand communicateCAPAsand action planstoCountryManagementand Corporate Quality
- Act asQualityliaison between the localoperationalgroups and Corporate Quality forGMP/GXP/GDPfunctions and activities.
- Partner with local, regionaland globaloperational groups to foster a proactive approach to compliance.
- 10-15years+ of Quality Assurance / Compliancemanagementexperience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicablelocalandglobalregulatory requirements requiredfor GXP compliance.
- Strong leadership ability.
- Goodknowledge of government regulations and guidelines (local,EMA, FDA, PMDA) pertaining toGXP, particularly those related to product distribution asrequired
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Exceptional communication and interpersonal skills
- Ability to work globally in a matrix environment
- Ability to influence senior management, peers and other colleagues without direct reporting lines
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- Ability to multi-task and prioritize work
- Strong organizational ability
- Demonstrable computer skill
- Ability tofreely travel up to 30%, (domestic and international)
- Bachelor's Degree in physical/life scienceor pharmacy;Advanced degreepreferable
- Interpersonal Savvy
- Global Business Knowledge
- Cross Cultural Agility
- Organizational Agility & Comfort Around Senior Management
- Dealing With Ambiguity
- Priority Setting
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. To learn more about Alexion, please visitwww.alexionpharma.comor download our App for iPhones and Blackberries.Alexion is an Equal Opportunity employer.