What are the responsibilities and job description for the Quality Compliance Specialist (Partner Change Control Notifications) position at BioSpace?
We are currently looking to fill a Quality Compliance Specialist position. This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications.
In this role, a typical day might include the following:
Acting as Regenerons representative in meetings with external partners to discuss changes for applicable products
Participating in internal cross functional teams on global change management of partnered products
Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures
Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification
Developing, monitoring, and communicating metrics to ensure the health of the partner notification process
Partners with counterparts to ensure global alignment of processes, systems, and procedures
Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
Assisting as needed in audits and inspections
Review and Approval of Partner Change Notifications
This Role Might Be For You If You
Are knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
Have aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
Have a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
Are proficient in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint, experience with Quality Management Systems preferred
Role
To be considered for this role you must hold a Bachelor's in a scientific or related field and the following minimum amounts of relevant work experience for each level:
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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)
$62,355.00 - $128,700.00
In this role, a typical day might include the following:
Acting as Regenerons representative in meetings with external partners to discuss changes for applicable products
Participating in internal cross functional teams on global change management of partnered products
Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures
Developing relationships with end users and providing advice on best practices/ strategy for changes that require partner notification
Developing, monitoring, and communicating metrics to ensure the health of the partner notification process
Partners with counterparts to ensure global alignment of processes, systems, and procedures
Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
Assisting as needed in audits and inspections
Review and Approval of Partner Change Notifications
This Role Might Be For You If You
Are knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another
Have aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
Have a proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
Are proficient in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint, experience with Quality Management Systems preferred
Role
To be considered for this role you must hold a Bachelor's in a scientific or related field and the following minimum amounts of relevant work experience for each level:
- Associate Specialist - 0 years
- Specialist - 2 years
- Senior Specialist - 5 years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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)
$62,355.00 - $128,700.00
Salary : $62,355 - $128,700