Manager, QA for QC Lab Support

The QA department is hiring! Join this newly formed team and own the Quality function as it relates to support of our Quality Control Laboratories  The individual will proactively identify and lead all aspects of implementation of industry standard processes for GMP across the quality control operations. This position will play a key role in influencing policy and procedure and promoting continuous improvement in the organization. 

As a Manager, Quality Compliance, a typical day might include the following:

• Interacts primarily with Quality Control laboratories (and other support functions such as Manufacturing, Process Sciences, QA Validation, IT, Facilities) to ensure a successful compliance profile.
• Leads all aspects of quality standards, systems, and metrics for laboratory operations and related manufacturing areas.
• Accountable for the performance, results, and timeliness of team.
• Ensures that procedures and products adhere to internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world. 
• May be involved in ensuring regulatory observations are adequately addressed and completed on schedule.
• Acts as a key quality assurance resource on matters related to Quality Control and as a leader between functional areas to ensure regulatory compliance.
• Collaborates with key partners globally in the business to proactively identify areas for improvement, develop solution strategies, and implement new innovations.
• Finds opportunities and participates cross-functionally to develop and implement tools and processes to improve systems, alleviate constraints, and resolve issues.
• Gains cooperation of others and effectively facilitates the resolution of cross-functional issues. Ensures effective, accurate, and timely communication across functional areas serving as a point of contact for Quality Assurance.
• Identifies areas of global mis-alignment and participates cross-functionally to understand differences, assess gaps, and drive relevant actions to remove gaps.
• Provides guidance and mentoring to co-workers to assist with troubleshooting, investigations, and effective problem resolution.
• Ensures safety and operational standards are maintained.
• May manage a team of individual contributors to support team goals.

This role may be for you if:

• Good understanding of analytical laboratory and biologics manufacturing operations is helpful; experience with facility or laboratory start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities
• Prior experience within a Quality Assurance or Quality Control function
• Good interpersonal skills and attention to detail
• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle multiple assignments and changing priorities.
• Ability to learn and apply computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines

In order to be considered for this position, you must hold a BS in life sciences subject area or related field and

• Manager: minimum 7 years experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience
• Senior Manager: minimum 8 years experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience
• Experience in the pharmaceutical/biotechnology industry (biotech preferred) desired

#REGNQA #LI-Hybrid

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.

Salary Range (annually)

$96,400.00 - $180,500.00