Associate Manager, Quality Systems (Lab Deviations)

Location
Rensselaer, NY, United States
Posted
Jan 10, 2019
Ref
14967BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The Associate Manager, Quality Laboratory Deviations supports direct oversight on the use and execution of Deviation Management System (DMS) for the quality control unit. The main objective is to ensure effective management and compliance of Laboratory Investigations, Deviation and CAPA for laboratory related events.

Essential Duties and Responsibilities will include one or more, but limited to the following:

• Leading and managing laboratory deviations team with direct QA oversight of investigations and associated CAPA(s).

• Ensuring global alignment of execution to deviation and CAPA related processes, procedures and methods.

• Maintaining compliance with Regeneron and global regulatory standards.

• Training and mentoring staff and system users.

• May be responsible for or contribute to development and management of training curriculum, training content and training content delivery related to laboratory operations within the DMS.

• Leading and participating in continuous improvement initiatives based on user feedback, process monitoring results, etc.

• Ensures assigned DMS element(s) systems/processes are appropriately managed and monitored for performance and metrics are appropriate to demonstrate system health and emerging opportunities for improvement.

• Reviewing, verifying and approving system records.

• Approving, authoring, and /or revising SOPs.

• Assists as needed in audits and inspections.

• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.

• Involved in daily operational activities.
Education and Experience:

• BA/BS degree and a minimum of 6 years of industry/relevant technical experience in quality systems or Quality Assurance role with +2 years proven record of managing employees.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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