Director, Global Medical Affairs Quality Operations

  • Alexion Pharmaceuticals, Inc.
  • Boston, MA, USA
  • May 23, 2018
Other

Job Description


Alexion Pharmaceuticals, Inc.

Alexion is an Equal Opportunity/Affirmative Action Employer.

Req ID: 13553
Job Category: Quality
Location: Boston, MA
Posting Date: May 21, 2018

Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal. Note that you will need to be connected to the VPN if you are applying away from the office.

Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com

Position Summary

This leader will:
  • Be accountable for the development and implementation of a global strategy to plan, control, and improve quality for all aspects of Global Medical Affairs (GMA) activities.
  • Serve as the lead for GMA compliance with global regulations for medical affairs activities for multiple products.
  • Influence GMA senior executives to successfully embed a strong Quality governance model including a dashboard of key quality performance indicators (KQPIs) to oversee the performance of the GMA Quality Management System (QMS)
  • Identify, evaluate, and drive the remediation of fundamental risks and issues within GMA to drive quality, in collaboration with GMA, across all GMA activities and programs.
  • Partner with Regional Quality representatives to assure understanding and application of global regulations in GMA activities.


Principal Responsibilities
  • In partnership with the GMA Leadership team, create an annual strategic quality management plan (QMP)
  • Serve as Quality Operations Lead for global GMA-related quality issue investigations and CAPA management process.
  • Be accountable for the strategy and execution of inspection readiness for GMA, Analyze the risks, propose the strategy for readiness and manage the implementation of the inspection readiness program.
  • Collect and monitor compliance metrics globally and evaluate possible trends and partner with GMA to develop global CAPAs as needed. Identify key GMA risks and support the implementation of GMA quality risk mitigation plans where appropriate.
  • Support development of risk-based audit strategies in partnership with GxP Audit, and partner with GMA to support preparating for audits and addressing audit findings.
  • Consult with Clinical Operations Quality Lead and GPV Quality Lead to ensure GCP/GVP compliance in GMA.
  • Develop or review relevant GxP SOPs governing Quality activities as well as other functional area activities.
  • Provide oversight for all quality issue management including audit reports, quality issues/incidents, and CAPA development, implementation and closure.
  • Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Serve as an internal expert in the management of GMA quality systems


Qualifications
  • Minimum 10 years' experience in GMA and quality assurance in both tactical and strategic capacities
  • Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
  • Significant experience with PV investigations, risk assessments and CAPA management
  • Experience participating in regulatory inspections
  • Functional planning experience and ability to develop functional vision, priorities and tactics
  • Experience with multinational products and regulations as well as with mandated risk management plans


Education
  • Bachelor's degree in life science required. Advanced degree strongly preferred.

*LI-DD1

Boston, MA, United States


Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.

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.alexion.com.



Alexion participates in E-Verify process. To learn more, please click on attached document(s)

English/Spanish

PI102555886