Director, Quality Systems

Location
Troy, New York, United States of America
Posted
Jul 24, 2021
Ref
R49
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Director Quality Systems position. This position is responsible for providing professional expertise and leadership in the Quality function. This role will proactively identify and implement industry standard methodologies for GMP across manufacturing, quality control, materials management and validation. This position 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.

In this role, a typical day might include the following:
  • Owns and continuously improves the Change Control Quality System
  • Interacts with critical biotechnology commercial and clinical API and Fill/Finish manufacturing operations, partners, 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 Quality System adheres to tight internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world
  • Integral in Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addressed and completed on schedule
  • Partner with critical contract manufacturers and partners to resolve compliance issues in supply chains, collaborate with customer/partner quality organizations, and create third party contractor and supplier quality agreements as needed
  • Work with the business as it relates to significant deviations and assist in establishment of approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution
  • Ensures safety and operational standards are maintained


This role might be for you if you:
  • Have prior experience in a managerial capacity within QA/QC
  • Have technical experience in a manufacturing operations function
  • Are able to influence others to achieve results and to challenge the status quo
  • Excel in a quality driven organization
  • Possess a broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations


To be considered for this role you must hold a Bachelor's degree in Life Sciences 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.

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