Sr Manager QA Validation

Summary: Leads department responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron’s Raheen facility. Participates and defends validation data in FDA and other regulatory inspections.

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

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Designs and develops policies related to validation and ensures that they are effectively administered and comply with regulatory requirements.

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Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions: Failure investigations / Change controls and associated Test Plan documentation / SOPs / Validation protocols and summary reports / Validation Master Plans

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Interviews, hires, orient, and trains incoming personnel.

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Manages Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks.

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Develops and manages validation budget, contracts, and schedules.

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Presents/defends validation data to FDA and other regulatory agencies.

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Maintains validation document and software control system.

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Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

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Organizes QA Validation resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.

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Plays a proactive role in developing and applying new approaches and processes to validation strategies.

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Regularly interacts with senior managers and executives to create a broad-based validation program.

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Applies complete functional knowledge and awareness of company goals and objectives.

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Counsels employees about work performance; conducts hiring and discharge interviews.

Education and Experience

• Requires BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes.

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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.