Director, GMP Data Governance (Site Lead)

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Job description

We are currently looking to fill a Director of GMP Data Governance position. This position acts as a link between global policy and standard setting and the local implementation of these within their site business unit(s). It plays an integral part in safeguarding the quality and reliability of the organizations data which is critical for informed decision making and regulatory compliance. The position requires a blend of technical knowledge within the biotech or pharmaceutical sector, coupled with positive relationship building and analytical thinking skills.

In this role, a typical day might include the following:

• Building, leading & managing of the site Data Ops & Engagement, Culture & Monitoring (ECM) team & the delivery/implementation of site DG responsibilities & standards.

• Successful collaborator engagement & management across the site.

• Establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established.

• Creation & delivery of DG training programs in consultation with Global Data Governance Senior Leadership Team.

• Ensures Site team is appropriately resourced, supported and has the tools & direction to accurately implement their function.

• Lead cultural & people change management efforts related to DG ensuring smooth adoption of new processes, systems, and ways of working within the relevant site.

• Partner with ECM Specialists for developing and embedding DG culture across all elements of site work.

• Work 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.

• Staying updated on the latest industry trends and regulatory changes within the biopharma industry and assessing the impact.

• Encouraging a culture of quality & DG within the organization.

• Promoting the importance of DG across all departments.

• Driving communication and teamwork between team members to ensure effective DG practices.

• Encouraging CI by actively seeking feedback and supporting initiatives crafted to improve data quality and governance.

• Leading/supporting initiatives to embed DG principles into core values and everyday practices.

This role may be for you if you:

• Have experience in implementing DG policies & initiatives within business units in a GMP regulated environment.

• Have 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.

• Understand data governance principles, regulatory requirements & industry standards, and the practical application of these in business operations.

• Possess extensive experience demonstrating ability to partner, influence and incorporate new standards.

• Have people management & team leadership experience.

• Are experienced in leading and implementing training programs & monitoring important metric achievement.

• Have strong collaborator management and influencing skills.

• Are adaptable in the face of changing business needs.

To be considered for this role you must hold a Bachelors degree and the following amount of experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations or IT, for each level:

• Associate Director 10+ years

• Director 12+ years

Professional qualification in Data Governance (e.g. CDMP, DGSP) is a plus.

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.

Salary Range (annually)

$142,700.00 - $277,100.00

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