BioSpace Limerick, County Limerick, Ireland
5 days ago – Be among the first 25 applicants
Within this role you will be responsible for leading a team that supports the Supply Chain IOPS management system and compliance‑related activities, including investigations, change controls, CAPA, etc., across all areas within Supply Chain Management.
Typical Day (Responsibilities)
* Develop an effective compliance framework for the Supply Chain department through the development and implementation of appropriate compliance‑related policies and procedures.
* Act as a liaison between the Supply Chain department and onsite quality and regulatory groups to define and address all issues of non‑compliance.
* Facilitate all reviews and revisions of all Supply Chain department‑related SOPs, plans and policies for each group within the department.
* Provide support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow‑up of documents such as change controls (CCs), notices of effect (NOEs), DNFs, impact statements and corrective action plans.
* Drive a proactive compliance environment in the Supply Chain team through completion of self‑audits, knowledge transfer and education of compliance‑related items.
* Coordinate with other functional groups to assess impact and obtain necessary review and approval of investigations.
* Keep team members informed of the status of assigned work.
* Lead and participate directly in the investigation process.
* Review investigation reports.
* Ensure Corrective & Preventative Actions are appropriate, implemented as planned and have the intended effectiveness.
* Identify recurring events and ensure appropriate actions are taken, such as management notification.
* Lead and manage Change Controls for Supply Chain.
* Work with the team to develop a robust training program.
* Maintain metrics to measure information flow in order to determine performance gaps.
* Provide leadership to specific assigned projects.
* Provide coaching to direct reports, including employee development plans, and foster a healthy work environment where employees feel valued and respected.
* Identify opportunities for improvement within Supply Chain Management and communicate those opportunities to management.
* Promote the achievement of corporate goals and objectives.
* Embrace and promote the IOPS culture and the Regeneron Way.
Qualifications
* Previous experience in compliance and project management within a cGMP environment.
* Strong working knowledge of supply chain management.
* Ability to manage multiple, complex projects and changing priorities, work extended hours when required, make sound decisions under pressure and work effectively in a team environment.
* Excellent time management, organizational skills and written and verbal communication skills.
* Proficiency in MS Office, Excel and Oracle.
* Ability to motivate and lead a team and supervise and coach staff.
* Experience with interviewing, hiring, training, coaching and disciplinary actions.
* Strong analytical skills and ability to communicate details clearly and effectively.
* Attention to detail, fact‑based, self‑motivated and ability to work under pressure.
To be considered for this opportunity you should have a BS/BA/BEng. A bachelor’s degree in Business, Supply Chain Management or a science background and 7 years of relevant experience in a cGMP environment or an equivalent combination of education and experience.
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 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.
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 health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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