Manager Compliance
Manager Compliance
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Salary Not Disclosed
1 Vacancy
Job Description
Manager Compliance
Location: New Haven CT or Boston Seaport.
This is what you will do:
The Compliance Manager is a leader within the Compliance team of the Product Development and Clinical Supply (PDCS) Organization. Will work independently with minimal supervision and is responsible for maintaining quality compliance in and across the PDCS Organization by identifying quality requirements; disseminating policies procedures deviations laboratory investigations change controls periodic reviews recommending improvement plans and performing compliance tasks.
Additionally the Compliance Manager will be responsible for chair meetings partnering with leadership and functional pillars by creating maintaining and progressing quality records within our Quality Management System (QMS) as well as participating and driving various governance exercises triage teams and review boards which provide oversight of these activities.
You will be responsible for:
Generating reviewing providing assessments and maintaining deviations laboratory investigations action items CAPAs and Change Control.
Identifying opportunities for improvement in systems and making recommendations for effective changes to ensure compliance with cGMP.
Creating timelines and plans to meet established targets goals and objectives established by PDCS leadership.
Chairing and leading internal meetings with crossfunctional team members.
Maintain dashboards to facilitate in house meeting regarding current quality records.
Mentoring and training of Compliance Team new hires to support Alexion core behaviors (We Put our Patients First We Play to Win and We do the Right Thing) which is part of everything we do for our patients our Guiding Star.
Identifying opportunities for improvement in systems and making recommendations for effective changes to ensure compliance with cGMP.
You will need to have:
A bachelors degree in the science field or substantial relevant industry experience in corresponding subject matter. And 58 years of relevant experience.
Subject Matter Expert of Veeva Vault or equivalent quality system for change control deviation CAPA Laboratory Investigation Reports (LIR).
Experience integrating new quality systems to support internal timelines and support PDCS speed to clinic initiative.
The duties of this role are conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and nonlinear thought analysis and dialogue; collaborate with others maintain general availability during standard business hours.
We would prefer for you to have:
Experience with quality improvement projects.
Experience with Veeva Vault EDMS or equivalent.
Experience with Vault EQV or equivalent Quality Management System (QMS)
Date Posted
06Mar2025Closing Date
19Mar2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.Required Experience:
Manager
Employment Type
Full-Time
