Alexion Pharmaceuticals, Inc.
The Senior Director, Global Operations Quality Compliance (SD, GOQC) has responsibility for oversight of compliance across Global Operations in support of GMP & GDP activities. The SD, GOQC will have responsibility for developing and implementation of a Global Supplier Quality Program. The role will also be responsible for leading the Global Audit Program that will identify risks to the Alexion network, drive compliance and continuous improvement of systems and process. The SD, GOQC will be responsible for developing and implementing a Global Inspection Readiness Program and will support Manufacturing Operations and Affiliates in all compliance related activities. The role will develop and lead a program for risk identification and management for Global Operations and will lead the identification of top risks across all sites and subsequent risk monitoring and reporting.
Job Duties & Responsibilities
Lead the development of a Global Inspection Readiness Program that will drive compliance and continuous improvement across Global Operations.
Responsible for management & oversight of Regulatory Compliance across Global Operations
Develop a process for identification and management of the top compliance risks across Global Operations Functions, which will also include analysis of audit & inspection data. Actively monitor the risk register and report on status to Senior Management.
Develop and Lead the Global Supplier Quality Program
Management of Supplier Management Review
Lead the Global Audit Program
Support the investigation of Quality/Compliance issues
Develop a globally aligned process for Health Authority Inspection mangement and follow-up to drive consistency across the business
Maintain the central repository for all inspection related data and regulatory intelligence.
Provide Health Authority Inspection support to the business to enable successful inspection outcomes.
Maintain the central repository for GMP Certificates
Maintain the budget for Global Quality Compliance
Hire, coach, developing staff
Minium 15 years experience in GMP Quality/Compliance environment and 5 years in a relevant managerial role
Experience leading and managing across a matrix with strong influence management experience and ability to manage a team of experts
Thorough knowledge of applicable international GxP regulations and standards
Ability to provide technical and compliance related direction
Ability to coordinate efforts across multiple functions to maintain optimal performance.
Sound pharmaceutical industry awareness and understanding, especially with respect to quality and regulatory requirements
Strong mature leader with influencing skills
Ability to represent the company both internally and externally
Strong verbal and written communication skills with ability to present to various audience levels
Strong ability to analyze systems, data
Capable of identifying and mitigating risks
BS/BA in science or related field. MS preferred
New Haven, CT, 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 is an Equal Opportunity /Affirmative action employer
Apply for this job at https://alexion.contacthr.com/60483086
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Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.