BioSpace
Manager, QA (Process Validation Oversight)
Join to apply for the Manager, QA (Process Validation Oversight) role at BioSpace.
Regeneron is hiring a Manager, QA (Process Validation Oversight) to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.
Typical Responsibilities
Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.
Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
Conduct one‑on‑one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.
What It Might Be a Fit For
Bring hands‑on validation experience in a GMP‑regulated environment.
Possess deep understanding and expertise in Process Validation.
Enjoy building strong, collaborative relationships across global internal teams.
Have a continuous improvement mindset.
Are an experienced leader who inspires and guides a multi‑tiered team.
Qualifications To be considered for this role, you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences and the following minimum years of experience for each level:
Associate Manager: 6+ years
Manager: 7+ years
May substitute relevant experience in lieu of education requirement. Level is determined on qualifications relevant to the role.
Salary Range (annually):
$90,800.00 - $173,400.00
We have an inclusive culture that provides comprehensive benefits that may include health and wellness programs, 401(k) company match, equity awards, annual bonuses, paid time off, and paid leaves 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, sex, national origin, age, citizenship status, marital status, disability, etc. 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.
#J-18808-Ljbffr
Regeneron is hiring a Manager, QA (Process Validation Oversight) to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.
Typical Responsibilities
Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.
Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
Conduct one‑on‑one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.
What It Might Be a Fit For
Bring hands‑on validation experience in a GMP‑regulated environment.
Possess deep understanding and expertise in Process Validation.
Enjoy building strong, collaborative relationships across global internal teams.
Have a continuous improvement mindset.
Are an experienced leader who inspires and guides a multi‑tiered team.
Qualifications To be considered for this role, you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences and the following minimum years of experience for each level:
Associate Manager: 6+ years
Manager: 7+ years
May substitute relevant experience in lieu of education requirement. Level is determined on qualifications relevant to the role.
Salary Range (annually):
$90,800.00 - $173,400.00
We have an inclusive culture that provides comprehensive benefits that may include health and wellness programs, 401(k) company match, equity awards, annual bonuses, paid time off, and paid leaves 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, sex, national origin, age, citizenship status, marital status, disability, etc. 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.
#J-18808-Ljbffr