Senior Manager Data Governance

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Munster, Ireland seeks a Data Governance Manager to ensure compliance with data standards and regulatory requirements. The role demands extensive experience in data governance, team leadership, and training program implementation. This position offers a collaborative environment and the opportunity to contribute significantly to data quality and governance initiatives.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• 8+ years of professional experience in data management, quality assurance, compliance, or related fields.
• Experience managing and implementing training programs.
• Knowledge of federal and local regulations like GDPR and FDA Guidance on Data Integrity.

Responsibilities

• Lead and manage Data Operations and Engagement.
• Drive communication and collaboration for effective data governance.
• Establish relationships with global Governance Team.

Skills

Data governance principles

Regulatory requirements

Analytical thinking

Relationship building

People management

Education

BA/BS degree

Job description

Overview

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within their site business unit(s). You will play an integral part in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance. You will possess a blend of technical knowledge within the biotech or pharmaceutical sector, coupled with positive relationship building and analytical thinking skills.

Responsibilities

• Leading & managing the site Data Operations & Engagement, Culture & Monitoring (ECM)
• Driving communication, engagement and collaboration across the site to ensure effective DG practices
• Establishing a collaborative relationship with the global Governance Team (Policies & Programs)
• Crafting & delivering DG training programs in consultation with Global Data Governance Senior Leadership Team
• Leading cultural & people organisational change efforts related to DG ensuring smooth adoption of new processes, systems, and ways of working within the relevant site
• Partnering with the ECM Specialists for developing and embedding DG culture across all elements of IOPS site work
• Collaborating with DG Business Partners for the successful delivery of global standards, policies and procedures at site level and the monitoring of adherence to these standards
• Encouraging CI by actively seeking feedback and supporting initiatives developed to improve data quality and governance

Qualifications & requirements

• A strong understanding of data governance principles, regulatory requirements & industry standards, and the practical application of these in business operations
• Extensive experience collaborating, influencing and implementing DG policies & initiatives within business units in a regulated environment
• People management & team leadership experience
• Experience of managing and implementing training programs & supervising critical metrics
• Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity

To be considered for this role you must hold a BA/BS degree and 8+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

Professional qualification in Data Governance (e.g. CDMP, DGSP) and knowledge of cGMP & GDP advantageous.

Does this sound like you? 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 (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 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.