What are the responsibilities and job description for the Manager, Compliance position at Alexion Pharmaceuticals, Inc.?
Location: This position has the ability to be based onsite in New Haven, CT or Boston, MA.
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:
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, CAPA’s 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 cross-functional 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.
- A bachelor’s degree in the science field or substantial, relevant industry experience in corresponding subject matter. And 5-8 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 office-based 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 non-linear thought, analysis, and dialogue; collaborate with others, maintain general availability during standard business hours.
- Experience with quality improvement projects.
- Experience with Veeva Vault EDMS or equivalent.
- Experience with Vault EQV or equivalent Quality Management System (QMS)
