Job Description
We are currently looking to fill a Manager, QA (Supplier Quality) position. This position coordinates the Quality Assurance initiatives for a broad range of topics relative to material and supplier quality including Supplier Management and Material Qualification. This role also supervises a team of Material Supplier and Compliance Specialists.
In this role, a typical day might include the following:
Accomplishes material and supplier quality objectives through team members and by planning and evaluating area activities.
Track status of quality records including document workflows (SOPs, material specifications, etc.), change controls, deviations, CAPAs, extensions, and SCARs.
Defines and implements quality standards, systems, and metrics for clinical and commercial operations.
Preparing and completing action plans while implementing productivity and quality.
Resolving problems, identifying trends, and deciding system improvements
Implementing change when vital within the guidelines of GMP.
Maintain project timelines associated with QA initiatives to support the evolving business.
Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
Support Regulatory and partner inspections as needed.
Lead quality events such as Deviations, Supplier Corrective Action Requests, CAPAs, and Extensions for the Material & Supplier Quality organization.
This role may be for you if you:
Have previous quality experience in the pharmaceutical industry.
You continuously seek to improve processes for improved performance.
Enjoy leading a team of Quality minded professionals.
Have previous leadership experience including leading a team to meet department goals, performance evaluation/feedback, and mentorship
To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and the following years of experience for each level:
Manager: 7+ years
Level is determined based on qualifications relevant to the role. Equivalent combination of education and experience may be considered.
\#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$89,100.00 - $170,100.00
In this role, a typical day might include the following:
Accomplishes material and supplier quality objectives through team members and by planning and evaluating area activities.
Track status of quality records including document workflows (SOPs, material specifications, etc.), change controls, deviations, CAPAs, extensions, and SCARs.
Defines and implements quality standards, systems, and metrics for clinical and commercial operations.
Preparing and completing action plans while implementing productivity and quality.
Resolving problems, identifying trends, and deciding system improvements
Implementing change when vital within the guidelines of GMP.
Maintain project timelines associated with QA initiatives to support the evolving business.
Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
Support Regulatory and partner inspections as needed.
Lead quality events such as Deviations, Supplier Corrective Action Requests, CAPAs, and Extensions for the Material & Supplier Quality organization.
This role may be for you if you:
Have previous quality experience in the pharmaceutical industry.
You continuously seek to improve processes for improved performance.
Enjoy leading a team of Quality minded professionals.
Have previous leadership experience including leading a team to meet department goals, performance evaluation/feedback, and mentorship
To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and the following years of experience for each level:
Manager: 7+ years
Level is determined based on qualifications relevant to the role. Equivalent combination of education and experience may be considered.
\#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$89,100.00 - $170,100.00