BioSpace
Associate Manager Manufacturing Compliance (Change Control)
BioSpace, Troy, New York, United States
Associate Manager Manufacturing Compliance (Change Control)
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Associate Manager Manufacturing Compliance (Change Control)
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BioSpace Associate Manager Manufacturing Compliance (Change Control)
1 day ago Be among the first 25 applicants Join to apply for the
Associate Manager Manufacturing Compliance (Change Control)
role at
BioSpace Get AI-powered advice on this job and more exclusive features. We are currently looking to fill an Associate Manager, Manufacturing Compliance (Change Control) position with a 1st shift Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Manager, Manufacturing Compliance (Change Control) leads a team with direct oversight of work for deviations, corrective actions, and all associated change controls.
This position will be open for applicants until COB 02Jun2025.
As Associate Manager, Manufacturing Compliance (Change Control), a typical day might include the following:
Designs business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) and process improvements in support of manufacturing operations. Reviewing, verifying and approving system records Reviews, edits, and revises controlled documentation in accordance with cGMP standards. Independently coordinates and/or leads cross-functional meetings with multiple departments to drive change control implementation. Provides advice and guidance to cross-functional teams to enable successful and GMP compliant change controls. Works cross-functionally to develop and propose streamlined implementation strategies for change controls of increased complexity. Recommends corrective actions based on investigational findings. Involved in post-production management of events as required to facilitate closures to meet the required timelines. Presents business critical and regulatory impactful change controls to senior leadership and during regulatory inspections Leads projects and participates in quality driven business initiatives. Independently performs advanced troubleshooting to identify and implement solutions to obstacles encountered by their team during the change control process. Tracks quality system metrics including deviations, corrective actions, change controls, and controlled document workflows. Develops strategies to streamline the ways of working; uses metrics/data to present findings and recommendations to management. Perform personnel management functions (i.e. annual employee evaluations, coaching, mentoring, training performance feedback, etc.).
This Role Might Be For You If You
Excel in a quality driven organization. Can navigate changing priorities through robust organizational, planning, and people management skills. Have a strong attention to detail. Have strong technical writing, interpersonal communication, and presentation skills. Can learn and utilize computerized systems for the performance of daily tasks. Have experience navigating a controlled quality system
Role
To be considered for this role you must hold a Bachelors degree in Life Sciences or related field and the following minimum amounts of relevant experience for each level:
Supervisor 5+ years Associate Manager - 6+ years
Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.
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)
$77,600.00 - $148,400.00 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Manufacturing Manager” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join to apply for the
Associate Manager Manufacturing Compliance (Change Control)
role at
BioSpace Associate Manager Manufacturing Compliance (Change Control)
1 day ago Be among the first 25 applicants Join to apply for the
Associate Manager Manufacturing Compliance (Change Control)
role at
BioSpace Get AI-powered advice on this job and more exclusive features. We are currently looking to fill an Associate Manager, Manufacturing Compliance (Change Control) position with a 1st shift Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Manager, Manufacturing Compliance (Change Control) leads a team with direct oversight of work for deviations, corrective actions, and all associated change controls.
This position will be open for applicants until COB 02Jun2025.
As Associate Manager, Manufacturing Compliance (Change Control), a typical day might include the following:
Designs business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) and process improvements in support of manufacturing operations. Reviewing, verifying and approving system records Reviews, edits, and revises controlled documentation in accordance with cGMP standards. Independently coordinates and/or leads cross-functional meetings with multiple departments to drive change control implementation. Provides advice and guidance to cross-functional teams to enable successful and GMP compliant change controls. Works cross-functionally to develop and propose streamlined implementation strategies for change controls of increased complexity. Recommends corrective actions based on investigational findings. Involved in post-production management of events as required to facilitate closures to meet the required timelines. Presents business critical and regulatory impactful change controls to senior leadership and during regulatory inspections Leads projects and participates in quality driven business initiatives. Independently performs advanced troubleshooting to identify and implement solutions to obstacles encountered by their team during the change control process. Tracks quality system metrics including deviations, corrective actions, change controls, and controlled document workflows. Develops strategies to streamline the ways of working; uses metrics/data to present findings and recommendations to management. Perform personnel management functions (i.e. annual employee evaluations, coaching, mentoring, training performance feedback, etc.).
This Role Might Be For You If You
Excel in a quality driven organization. Can navigate changing priorities through robust organizational, planning, and people management skills. Have a strong attention to detail. Have strong technical writing, interpersonal communication, and presentation skills. Can learn and utilize computerized systems for the performance of daily tasks. Have experience navigating a controlled quality system
Role
To be considered for this role you must hold a Bachelors degree in Life Sciences or related field and the following minimum amounts of relevant experience for each level:
Supervisor 5+ years Associate Manager - 6+ years
Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.
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)
$77,600.00 - $148,400.00 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Internet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Manufacturing Manager” roles.
Albany, NY $75,000.00-$95,000.00 1 week ago Director, External Manufacturing Compliance
Executive Director Internal Fill/Finish Manufacturing
Executive Director Internal Fill/Finish Manufacturing
Schenectady, NY $122,600.00-$135,000.00 2 days ago Schenectady, NY $80,000.00-$90,000.00 2 days ago Lean Leader - Schenectady Cores and Castings
Operations Leader/Production Supervisor - Generator Manufacturing 1st Shift
Regional Operations Manager - New York East
Manufacturing - Digital Manufacturing, Senior Manager
Schenectady, NY $80,000.00-$90,000.00 1 week ago Supervisor Manufacturing Compliance (Change Control)
Associate Manager Manufacturing Compliance (Change Control)
Schenectady, NY $80,000.00-$90,000.00 2 weeks ago Manufacturing, Maintenance Supervisor, Schenectady, NY (USA)
Schenectady, NY $75,000.00-$95,000.00 2 weeks ago Albany, NY $40,000.00-$43,500.00 1 week ago Operations Leader/Production Supervisor - Generator Manufacturing 1st Shift
Supervisor Manufacturing Compliance (Change Control)
Ravena, NY $67,200.00-$93,300.00 2 weeks ago Special Assistant (Working Title: Director of Manufacturing and Incubation Programs)
Albany, NY $90,931.00-$114,940.00 4 days ago Associate Manager, Quality Assurance (Visual Inspection)
Albany, NY $53,000.00-$62,000.00 4 days ago Associate Manager, Quality Assurance (Visual Inspection)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr