As a Senior Compliance Specialist, you will act as the audit readiness point of contact for the QC team and GCI. You will ensure the organization's adherence to regulatory standards, drive compliance excellence, and support GMP inspection readiness. Your role will involve managing compliance documentation, laboratory investigations, and deviation management, ensuring alignment with GMP, IOPS, and other regulatory requirements.
A typical day might include, but is not limited to, the following:
* Organising GMP inspection readiness activities, including scheduling and SME preparation for on-the-floor inspections.
* Preparing and actively managing post-inspection activities to ensure timely resolutions and follow-ups.
* Supporting the IOPS QC organization by identifying quality improvements and leading projects to enact those improvements.
* Reviewing, editing, and revising controlled documents such as logbooks and SOPs to ensure compliance with cGMP standards.
* Monitoring QC processes to acquire vital data in support of investigations and tracking the efficiency of implemented changes.
* Gathering, trending, and analyzing QC process-related data to drive consistency and timeliness in compliance practices.
* Conducting cross-functional laboratory investigations that may span the entire QC department and coordinating resources from multiple teams.
* Representing QC in interdepartmental teams and meetings to align compliance strategies across functions.
* Striving for continuous improvement in laboratory practices to foster GMP compliance and meet different regulatory expectations.
* Communicating findings and recommendations at group and cross-functional meetings to ensure transparency and accountability.
* Training new employees on investigative processes, techniques, and audit readiness to build a culture of compliance.
Additional responsibilities for Analysts may include, but are not limited to:
* Leading cross-functional meetings to address GMP inspection readiness and laboratory investigation challenges.
* Increasing involvement in mentoring and training employees on compliance-related processes and systems.
* Increasing responsibilities for authoring and reviewing technical documents, including investigation reports, risk assessments, and corrective actions.
* Supporting compliance representation and participation in cross-functional site meetings to align with organizational goals.
* Performing technical writing assignments, such as laboratory investigations, audit findings, and continuous improvement plans
To be considered for this opportunity you should have BSc/BEng in scientific discipline or related field with 5+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
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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 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 Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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.