What are the responsibilities and job description for the Manager Quality Compliance (Complaints) position at BioSpace?
Regeneron is currently looking for a Manager, Quality Compliance (Compliant Investigations).This role will lead a team providing QA oversight of site compliance, with a primary focus on product quality complaint and trend investigations for commercial and clinical products. This role reviews and approves documentation, evaluates evidence and records (internal and external), designs experiments to test hypotheses, and authors technical reports/protocols to support investigation conclusions. The manager partners cross-functionally with Manufacturing (internal/external), Quality Control, Quality Assurance, and Global Patient Safety to meet regulatory requirements and site standards, advising on compliance best practices and stepping in as needed to meet timelines and resolve issues.
As a Manager Quality Compliance, a typical day might include the following:
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.
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)
$92,200.00 - $206,100.00
As a Manager Quality Compliance, a typical day might include the following:
- Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; this work may be done through direct reports.
- Oversees investigations (product quality complaints and trending) related to dissatisfaction by end user related to commercial and clinical products.
- Provides guidance on investigation plans related to complaints documentations, photographic evidence, return samples and is available support investigations.
- Participates in regulatory and customer audits.
- Identify gaps in systems and develop feasible plans for correction
- Mentor direct reports and functional area counterparts in compliance requirements.
- Facilitating continuous improvement initiatives specific to function.
- Ensuring appropriate training programs are implemented for related to function.
- Other related responsibilities as assigned.
- 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 knowledge/exposure to project management
- Have proficiency in Microsoft Office Programs
- Assoc Manager, Quality Compliance: 6 years
- Manager, Quality Compliance: 7 years
- Sr. Manager, Quality Compliance: 8 years
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.
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)
$92,200.00 - $206,100.00
Salary : $92,200 - $206,100