Director, GMP Inspection Management - OneTen Coalition
Valley Falls, NY
About the Job
We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes.
In this role, a typical day might include the following:
This role may be for you if you:
To be considered for this role you must hold a Bachelor's degree in chemical engineering/chemistry/life sciences and the following amount of related experience, preferably in the pharmaceutical or biotech industries or related field, for each level:
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#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)
$142,700.00 - $277,100.00
In this role, a typical day might include the following:
- Compliance
- Apply strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to sophisticated problems.
- Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
- Define and implement systems, and metrics for maintaining regulatory compliance all operations.
- Perform evaluations of GMP compliance across all areas of the site as well as procedures and processes.
- Collaborate with customer/partner quality organizations.
- Participates on internal committees/teams, as required.
- Provides advice and direction to other departments on quality and regulatory issues.
- Inspection Readiness
- Benchmark leading practices and recommend improvements to make IOPS inspection-ready at all times.
- Maintain inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
- Build and implement tools to improve IOPS inspection readiness.
- Identify trends in recent regulatory inspections and translate this to recommendations to improve readiness.
- Work closely with other regulatory compliance team to close gaps and improve inspection readiness capabilities.
- Inspection Execution
- Liaison with regulatory bodies, and partners on audit, regulatory, and quality related matters. Will also provide advice to partners, and internal associates on regulatory and quality matters.
- Respond to incoming inquires during inspections and audits and ensure timely and accurate during audit response.
- Coordination of responses to regulatory or partner audits
This role may be for you if you:
- Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
To be considered for this role you must hold a Bachelor's degree in chemical engineering/chemistry/life sciences and the following amount of related experience, preferably in the pharmaceutical or biotech industries or related field, for each level:
- Associate Director - 10+ years
- Director - 12+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
#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)
$142,700.00 - $277,100.00
Source : OneTen Coalition