Associate Manager, QA Validation

Rensselaer, NY, United States
Jul 13, 2019
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: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.

• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results.

• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports

• Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs

• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Approves various documents relating to area function, including those listed above.

• Provide direction and assign work to Validations Specialists to meet goals and timings

• Coordinates prioritization of activities with area management.

• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.

• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.

• Participates in regulatory and customer activities.

• Collaborates with functional departments to resolve issues.

• Manages projects and prepares status reports.

Education and Experience:

• Requires a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 6+ years of related experience within the field; may consider substiting relevant experience for education. Experience leading, supervising, or managing others required.

• Experience with cold chain management is preferred.

*Level will be determined based on skills and related experience.*

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.