Director, External Manufacturing Compliance, Albany

Director, External Manufacturing Compliance

New Yesterday

We are currently looking to fill a Director of External Manufacturing Compliance position. This position will supervise a team that supports the various compliance activities associated with all products manufactured in Regeneron’s External Manufacturing network in accordance with mandated regulatory requirements, Regeneron Quality Systems, and site expectations. In this role, a typical day might include the following: Provides leadership and support to prioritize, resource, guide, strategize and deliver upon compliance requirements

Establish standard processes in all compliance related activities, collaborate and partner with quality compliance groups, strategically meet goals and lead External Manufacturing cGMP Policies and SOPs

Leads and prioritizes operations and practices for supporting CMO and/or Partner Change Notifications, Change Controls, SCAR’s, Deviations and CAPA’s for clinical and commercial manufacturing across External Manufacturing

Provides performance metrics status and continuous improvement needs to CMOs at regular Operations Steering Committees

Is responsible for Inspection Readiness strategies in relation to any regulatory inspection or quality audit involving outsourced manufacturing, provides advice and on-site support to CMO /Partner sites during regulatory, provides support to internal Regeneron audits

Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, new and developing cGMP regulatory requirements and trends

Develops, trains and coaches Compliance and Manufacturing Specialists to lead or support closure of Quality System records

Collaborates with Quality Assurance, External Manufacturing teams to effectively address observations and drive CAPAs, SCAR’s, CC’s to completion

Travel up to 40% is required (domestic and international)

This role may be for you if you: Demonstrate a proactive approach to issue resolution with an ability to work well across various departments as well as business partners

Have excellent interpersonal, cross-cultural, communication and problem-solving skills

Possess experience interacting with Contract Manufacturing Organizations and leading in the Compliance/QA/QC field

Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).

Are a leader committed to team growth and staff development

Proficient in German, French and/or Spanish (oral and written) is a plus.

To be considered for this role you must hold a Bachelors degree and the following amount of pharmaceutical aseptic manufacturing experience in compliance, quality assurance or manufacturing related roles, for each level: Director – 12+ years

Sr Director – 15+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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Location:: Albany

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