What are the responsibilities and job description for the Manager Quality Assurance, Compliance position at BioSpace?
Build Our Future Together
Regeneron is currently seeking a Manager Quality Compliance to join our Quality Assurance (QA) team. This role is responsible for managing the compliance, audit, training and operations team for the internal fill finish site. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Discover Your Role
Lead and develop the QA compliance team: set work plans and objectives, prioritize and assign tasks, coach performance, and manage hiring and separations while aligning deliverables with company goals
Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives, and provide concise, actionable project reporting
Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure
Drive audit readiness and execution: align QA practices with requirements, run the audit-ready-365 program, plan and track coaching, and support internal and regulatory audits, including coordinating requests for the internal fill-finish team
Promote cross-site continuous improvement by collaboratively identifying gaps and sharing best practices
Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices
Stay current on industry trends and regulatory updates and translate insights into changes and improvements
The Environment And Physical Rhythms Of The Role
Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
This Role Requires
BS/BA in Life Sciences or related field; or equivalent combination of education and experienceAssociate Manager Quality Compliance: 6 years of relevant experience
Manager Quality Compliance: 7 years of relevant experience
Sr. Manager Quality Compliance: 8 years of relevant experience
Level will be determined based on experience
Experience with drug product manufacturing and/or fill finish
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
Regeneron is currently seeking a Manager Quality Compliance to join our Quality Assurance (QA) team. This role is responsible for managing the compliance, audit, training and operations team for the internal fill finish site. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Discover Your Role
Lead and develop the QA compliance team: set work plans and objectives, prioritize and assign tasks, coach performance, and manage hiring and separations while aligning deliverables with company goals
Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives, and provide concise, actionable project reporting
Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure
Drive audit readiness and execution: align QA practices with requirements, run the audit-ready-365 program, plan and track coaching, and support internal and regulatory audits, including coordinating requests for the internal fill-finish team
Promote cross-site continuous improvement by collaboratively identifying gaps and sharing best practices
Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices
Stay current on industry trends and regulatory updates and translate insights into changes and improvements
The Environment And Physical Rhythms Of The Role
Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
This Role Requires
BS/BA in Life Sciences or related field; or equivalent combination of education and experienceAssociate Manager Quality Compliance: 6 years of relevant experience
Manager Quality Compliance: 7 years of relevant experience
Sr. Manager Quality Compliance: 8 years of relevant experience
Level will be determined based on experience
Experience with drug product manufacturing and/or fill finish
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)