Principal QA Specialist

In this role you will work as an integral member of the QA Operational Team and collaborate with QA Operations; Document Control; QA Raw Materials and QA Systems.

A typical day might include, but is not limited to, the following:

• Collaborating with cross functional teams to resolve issues, complete investigations and maintain compliance

• Reviewing and approving documents such as failure investigations associated with deviations and Corrective and Preventative Actions (CAPA's), SOP’s, GxP documents, Change Control documents

• Leading and supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver

• Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements

• Providing guidance, mentoring and training to teams

• Supervising and trending metrics associated with site quality systems

• Providing support for Inspection readiness tasks and participating in internal, regulatory and customer audits

This role may be for you if you:

• Demonstrate excellent attention to detail

• Have strong organisational and coordination skills

• Demonstrate excellent interpersonal and communications kills

To be considered for this role, you should have a BS/BA in scientific discipline or related field and a minimum of 5 years of relevant work experience in pharmaceutical or related cGMP environment/industry preferably with compliance management experience, or equivalent combination of education and experience.

Sr QA Specialist: BS/BA in a scientific discipline plus 5 years experience

Principal QA Specialist: BS/BA in a scientific discipline plus 8 years experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€63,200.00 - €103,200.00