Manager/Sr Manager QA Operations

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager / Sr Manager QA Operations to join our QA Operations Batch Review team. In this role, you will be responsible for the management and oversight of the QA Operations function.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Raheen, Limerick

Discover your role:

• Directing and continuously improving QA Operations processes ensuring that performance and quality conform to regulatory standards and internal requirements.
• Driving initiatives that support departmental growth and organizational objectives to improve processes, reduce waste and improve efficiency.
• Providing leadership and collaboration within and across the organization at all levels, across functional groups.
• Partnering with US counterparts to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements.
• Identifying risks to operations and collaborating with the team and business to identify and implement mitigations.
• Ensuring appropriate resourcing for document schedule planning adherence.
• Developing resourcing strategies to plan and manage the operating budget and headcount budget and forecasting to ensure maximum utilization of personnel to fulfill department objectives
• Defining and implementing quality standards, systems, and metrics for QA Operations to ensure performance, compliance, effectiveness, efficiency, and value to the business in line with department goals.
• Reporting the status of process performance and ensuring that they are on-time and accurate metrics for presentation.
• Site support for QA Operations global teams, projects, and initiatives; continuously partnering with counterpart site leads.
• Involved in Regulatory Agency interactions and preparation as related to site inspections and ensuring regulatory observations in their area are adequately addressed and completed on schedule.

This role requires:

• Requires BSc/BEng in scientific discipline or related field with 8+ years’ experience in a pharmaceutical/biologics manufacturing environment desired or equivalent combination of education and experience.
• You have strong organisational capabilities and demonstrate good attention to detail.
• You are a self-starter with the ability to prioritise and handle multiple tasks simultaneously, operating effectively both independently and within a team environment.
• You have the ability to prioritise and handle multiple tasks simultaneously.
• You have the ability to own responsibilities and processes and to adapt to changing circumstances.

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)