Rensselaer, New York
Regeneron Pharmaceuticals, Inc.
We are currently looking to fill a Project Manager, Quality Assurance position. This position builds the Quality System foundation for new business relationships within the QA department. This role will be responsible for identifying the quality system interfaces that are needed between the companies for each relationship and build a process if there is not one already in place. After integration is complete and work is routine the workstream will be handed off to the quality unit responsible for day to day operations. The main objective is to ensure successful startup of new external relationships within the Quality Unit.
In this role, a typical day might include the following:
• Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external)
• Maintaining compliance with Regeneron and global Regulatory standards and helping to establish standards where needs have been identified
• Assessing process/system effectiveness and efficiency
• Monitoring Process Performance over time
• Ensuring systems are fully implemented and coordinated with other quality management systems
• Developing and providing tools to enable system understanding across multiple organizations
• Leading continuous improvement initiatives based on user feedback and process monitoring results
• Authoring and revising SOPs
• Assisting as needed in audits and inspections
• Interacting with senior internal personnel and external partners on significant matters often requiring coordination across facility locations
• Keeping educated of changes in regulatory requirements as it pertains to drug product manufacturing. Through partnering with internal and externals drug product teams, sharing this information to increase the collective understanding and implication of these changes.
This role may be for you if you:
• Have comprehension of quality and cGMP principles, Quality Management Systems, and relevant Global regulatory guidelines
• Have experience with Quality Assurance Agreements and Supply Agreements
• Have experience with Cell or Gene Therapy, or with a manufacturing start up or process development
• Are experienced in Project Management principals
• Possess excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences
To be considered for this role you must hold a Bachelor’s degree in a scientific subject area with 8+ years of related experience in a pharmaceutical / biologics cGMP environment for the Associate Project Manager level, 10+ years experience for the Project Manager level. 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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