Associate Director Quality Control

Rensselaer, NY, United States
Sep 04, 2019
Quality, Quality Control
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: Responsible for managing the operations of QC Chemistry laboratories including investigations and deviations.

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

• Provides key leadership, vision and direction to the QC group while providing operational expertise and excellence in the area of Laboratory Controls.

• Effective leadership and development of the QC Staff.

• Coordinate timely and right the first time delivery of test results required by Manufacturing Operations groups, Validation and Process Science groups.

• Acts as a key liaison between Quality Control, Manufacturing and Quality operations on-site.

• Maintaining a functional and compliant laboratory operation.

• Provide chemical expertise and support for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations.

• Overseeing day to day operational support of the QC labs testing operations through timely investigation, management of deviations and CAPAS.

• Effectively leading the QC team to support strong interactions and partnerships with manufacturing teams.

• Providing leadership and direction to Quality Control leads and Managers and support teams to ensure relevant KPIs are consistently met.

• Managing and developing the performance of direct reports by setting clear expectations.

• Ensuring timely issue escalation to Quality senior management and cross-functional support teams.

• Ensuring analysts are appropriately trained before any task execution.

• Participating in inspections conducted by external regulators and business partners.

• Maintaining a functional and compliant laboratory operation.

• Providing chemical expertise and support for training, product investigations, deviations, CAPA, quality and operational improvements, etc. to ensure continued compliance with regulations.

Knowledge, Skills & Abilities:

• Ability to communicate and lead with transparency

• Continuously drive to improve processes for improved performance

• Lead department for optimal performance and set course for future

• Accountable for performance and results of department

• Business continuity and long-term planning

• Ability to influence outside of own department

• Create departmental goals and assign resources based on business needs

• Effectively communicate vision for department

• Evolving knowledge of global organization and industry trends

Education and Experience:

• Requires a BA/BS in biochemistry, chemistry or related field with 10+ years of supervisory experience in an analytical testing laboratory along with quality control experience working in a cGMP environment.

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.