Manager, QA Validation Oversight
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Troy, New York
- Start date
- Jan 12, 2023
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The QA Validation Oversight team is hiring! The Manager will lead the QA Validation Review teams across all Regeneron IOPS, will provide quality oversight and management support to all validation activities for IOPS.
As a Manager, QA Validation Oversight, a typical day might include the following:
- Leads department responsible for qualification of manufacturing and laboratory equipment, utilities, software, and validation of manufacturing, cleaning and sterilization processes in Regeneron’s Rensselaer facility.
- Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
- Participates in regulatory and customer activities. Participates and defends validation data in FDA and other regulatory inspections.
- Collaborates with functional departments to resolve issues.
- Review and provide quality oversight of the deliverables of validation activities, including, but not limited to: Shipping, Equipment, Computerized Systems, QC and methods, and Process Sciences.
- Designs and develops policies related to validation and ensures that they are optimally coordinated and align with regulatory requirements
- Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions including failure investigations, SOPs, Validation protocols and summary reports and Validation Master Plans
- Interviews, hires, orient, and trains incoming personnel.
- Manages Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks.
- Presents/defends validation data to FDA and other regulatory agencies.
- Maintains validation document and software control system.
- Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.
- Coordinates QA Validation resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
- Plays a proactive role in developing and applying innovative approaches and processes to validation strategies.
- Regularly interacts with senior managers and executives to build a broad-based validation program.
- Applies complete functional knowledge and awareness of company goals and objectives.
- Counsels employees about work performance; conducts hiring and discharge interviews.
In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and
- Associate Manager: 6+ Quality and Validation of pharmaceutical, biopharmaceutical or gene therapy facilities and processes
- Manager: 7+ years of experience in Quality and Validation of pharmaceutical, biopharmaceutical or gene therapy facilities and processes
- Experience leading, supervising, or managing others required.
Salary Range (annually)
$86,900.00 - $166,000.00Company
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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