We are currently looking to fill a Supply Compliance Analyst. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Supply Compliance Analysts initiate, lead and execute compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within Supply Chain Management.
As a Supply Compliance Analyst, a typical day might include the following:
• Developing an effective compliance framework for all Supply Chain departments through the development and implementation of appropriate compliance related policies and procedures.
• Acting as a liaison between the Supply Chain departments and onsite quality and regulatory groups to define and address all issues of non-compliance.
• Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department.
• Providing support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow-up of documents such as CCs, NOEs, DNFs, impact statements and corrective action plans.
• Driving a proactive compliance environment in all the Supply Chain teams through completion of self-audits, knowledge transfer and education of compliance related items.
• Supporting partner and regulatory audits for supply chain function.
• Completing all required documentation in a manner which ensures compliance with all associated procedures.
• Working with Supply Chain personnel to understand the scope of investigations as well as the business need.
• Completing all associated documentation, forms and pre-work associated with change controls/investigations.
• Working with other functional groups to assess impact as well as obtaining necessary review and approval of investigations.
• Ensuring that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Leading and/or participating directly in the investigation process.
• Writing and/or reviewing investigation reports.
• Ensuring Corrective & Preventative Actions are appropriate, implemented as planned and have the intended effectiveness.
• Identifying recurring events and ensuring appropriate actions are taken, such as notifying management.
• Keeping team members informed of the status of assigned work.
• Leading and managing Change Controls for Supply Chain.
• Working with the team to develop robust training programs.
• Finding opportunities for improvement within Supply Chain systems and communicates those opportunities to management.
This role might be for you if you:
• Possess excellent written and verbal communication skills.
• Have strong analytical and organizational skills.
• Prioritize, re-prioritize as needed and adapt to change.
• Are comfortable working in a fast-paced setting.
• Seek to build relationships with customers and internal key stakeholders.
• Thrive in an ambiguous environment and are able to translate ambiguity into impactful steps.
• Courageous in asking the right questions in a cross-functional setting.
• Have demonstrated ability in MS Office, Excel, Oracle, PowerPoint and Access Database.
• Focus on continuous improvement.
• Have Lean/Continuous Improvement knowledge a plus.
• Completed APICS or other related purchasing certifications a plus.
To be considered for the Supply Compliance Analyst you must have the following; a bachelor’s degree in Business, Supply Chain Management or Science background at Associate Analyst. Analyst level requires a bachelor’s degree in Business, Supply Chain Management or Science background and 2 years of experience in investigations/change controls in a cGMP. Senior Analyst requires bachelor’s degree in Business, Supply Chain Management or Science background and 5 years of experience in investigations/change controls in a cGMP environment. Experience in pharmaceutical / biotech industry and in a cGMP environment is a plus. Equivalent combination of education and experience will be considered. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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