We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications.
As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include the following:
• Acting as Regeneron’s 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
• Responsible for leading, mentoring and developing direct reports.
This role might be for you if:
• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
• Demonstrated 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
• Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
• 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
• Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred
To be considered for this role you must hold a Bachelor's in a scientific or engineering discipline or related field and the following minimum amounts of relevant work experience in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements for each level:
-
Specialist - 2+ years
-
Senior Specialist -- 5+ years
Experience in change control function strongly preferred. 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)
$65,100.00 - $124,300.00
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media.
An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
