Job Overview:
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This is an exciting opportunity to join our team as a Manager of Quality Control. In this role, you will be responsible for overseeing the quality control support operations and providing direction to managers and staff who support equipment.
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Key Responsibilities:
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* Maintain oversight of QC equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning.
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* Provide direction to managers and staff who support equipment, ensuring equipment qualification and maintenance programs are aligned with regulatory agency requirements.
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* Interact with QC partner groups to establish internal requirements for equipment, leading QC equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups.
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* Manage oversight of preventive and corrective maintenance monitoring program, as well as QC external laboratories activities and performance monitoring of external testing laboratories.
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* Supervise the issuance and approval of quality agreements and SLAs with contract labs, verifying that site manufacturing licenses and global procedures reflect current contract lab utilization.
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* Identify and call out issues at contract laboratories to QC leadership, sourcing, coordinating, and project managing GMP activities relating to new contract lab introduction.
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* Travel may be required in support of external contract laboratory testing activities, performing personnel management functions, including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
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Requirements:
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To be considered for this opportunity, you should possess strong communication and interpersonal skills, demonstrate logical troubleshooting and problem-solving skills, have a detailed understanding of equipment qualification and maintenance activities, and industry compliance norms.
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You should also have the ability to communicate effectively with multiple partners, enjoy working in a fast-paced environment, and demonstrate a collaborative and team-orientated approach.
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Additionally, you should have a BA/BS in chemistry, biology, or related field, with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience.
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Benefits:
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We offer an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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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.
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The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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About Us:
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We are committed to creating a work environment that is inclusive and respectful, where everyone has the opportunity to contribute and succeed.
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If you are passionate about making a difference in the lives of others and thrive in a dynamic environment, we encourage you to apply for this exciting opportunity.
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