Summary: Leads and may manage individuals who accomplish project objectives by planning and evaluating project activities. Supports Quality Assurance project initiatives, Regulatory and Partner inquires, Specifications, as well as audit activities for a broad range of topics relating to Materials and Supplier Quality.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Approve various documents related to area function including but not limited to PPQ assessments, Supplier evaluations, Change Controls, Regulatory responses, partner inquiries and new material introductions
- Represent the Material & Supplier Quality group on new projects
- Define and implement projects to improve quality standards, systems, and metrics for clinical and commercial operations
- Responsible for coordination and implementation of Raw Material Single-use Specifications
- Coordinate and Organize QA resources to meet goals and timing with Area Management
- Review Regulatory, Partner, and customer requirements and participate, or may lead, a group for implementation of required processes to meet expectations regarding Quality
- Participate in Regulatory, Partner, and Internal Audits/Inspections and ensure observations are addressed and completed on schedule
- Participate in discussions regarding Supplier Approval, Change Notification, Change Control, and Deviations as required
- Create, Review, and/or Approve Quality Assurance Agreements
- Participate in Continuous Improvement initiatives
Education and Experience:
- Requires BS/BA degree in Life Sciences or related field
- Sr Specialist 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries or equivalent combination of education and experience.
- Principal Specialist 7+ preferably in the pharmaceutical or biotechnology industries or equivalent combination of education and experience.
- People management experience preferred but not required.
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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 parental 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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