Associate Manager Automation Compliance
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY, United States
- Start date
- Sep 17, 2019
View more
- Discipline
- Engineering, Automation Engineer, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary: Responsible for overseeing a team of Engineering Compliance Specialists in the Rensselaer Technical Operations Automation department that manages deviation investigations, implements Corrective and Preventive Actions (CAPA), supports regulatory inspections, authors SOP and Life Cycle Documentation, facilitates change controls, as well as other compliance tasks/functions.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for ensuring training, development, and compliance of direct reports.
- Sets priorities for Automation Compliance department.
- Tracks progress on Automation quality system deliverables, including deviation investigations, CAPAs, and change controls, ensuring quality and accuracy of documentation and adherence to due dates.
- Provides tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions) and other compliance metrics for the Automation department.
- Interfaces regularly with Quality Assurance, Engineering, Manufacturing, Facilities, and other functional areas in order to facilitate decisions pertaining to quality system deliverables.
- Performs and supports investigations and root cause analysis for equipment-related and compliance-related events.
- Owns change controls on behalf of subject matter experts and interprets testing requirements based on technical documents provided by subject matter expert.
- Develops and updates departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, and System and software lifecycle documents.
- Evaluates Automation department systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed.
- Acts as a liaison between Automation and Quality/Regulatory groups to address compliance-related items.
- Facilitates and/or assists Automation Department in preparation of regulatory inspections.
- Acts as a department liaison during regulatory inspections and coordinates post-inspection activities.
Education and Experience:
• Requires BS or higher in engineering and 6+ years of related experience. MBA or similar advanced degree preferred. Will substitute equivalent years of direct experience for education.
• Experience working in a cGMP environment or in a regulated industrial facility strongly preferred.
• Direct experience with industrial automation equipment preferred.
• 2-3 years of experience in a leadership role is preferred.
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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