Director, Quality Assurance (Bulk API Operations)

Troy, New York
Oct 23, 2021
Required Education
Bachelors Degree
Position Type

We are currently looking to fill a Director, QA Bulk API Operations position. This position is responsible for providing professional expertise and leadership in the Quality function. Individual will proactively identify and implement industry standard methodologies for GMP across manufacturing, quality control, materials management and validation. Individual will play a major role in the transition to a more commercial manufacturing operation while remaining adaptable to the changing needs of the clinical programs. Individual will have oversight of all batch review operations for commercial and clinical operations.

In this role, a typical day might include the following:

  • Owns and continuously improves the batch review operations for Quality in the Regeneron Bulk API manufacturing facility

  • Interacts with critical biotechnology API and Fill/Finish manufacturing operations (globally), facilities and Quality Control laboratories to ensure a successful compliance profile

  • Defines and implements quality standards, systems, and metrics for clinical and commercial operations

  • Ensures that products adhere to tight internal standards as well as those of the agencies that supervise the pharmaceutical industry around the world

  • May be involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addressed and completed on schedule

  • Partners with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, works with customer/partner quality organizations, and develops third party contractor and supplier quality agreements

  • Authorizes significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution

  • Ensures safety and operational standards are maintained

This role may be for you if you:

  • Are experienced in the pharmaceutical/biotechnology industry (biotech preferred)

  • Have managerial experience within QA/QC, as well as technical experience in a manufacturing operations function and experience with facility start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities

  • Demonstrate leadership skills

  • Excel in a quality driven organization

To be considered for this role you must hold a Bachelors degree and the following minimum amounts of pharmaceutical/biotechnology industry experience for each level:

  • Associate Director - 10+ years

  • Director - 12+ years,

  • Sr Director - 15+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.