Principal Gmp Data Governance Business Partner

In this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations.
You will be a site resource and subject matter expert on good DG practices and ensure Business Groups are aligned to the IOPS Data Governance Program.
Your remit will involve supporting the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program.
In this role, a typical day might include the following: Implementing standards, policies and procedures within allocated areas of the business Being the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans Assessing allocated business unit's current policies and processes and oversee the achievement of local DG KPIs Conducting regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections Working in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow continuous improvement and evolution of the DG approach Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments Driving communication and collaboration between stakeholders to ensure effective DG practices Encouraging CI by actively seeking feedback and supporting initiatives designed to enhance data quality and governance Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices This role may be for you if you 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 Demonstrated success in implementing and managing policies and standards within a regulated environment Excellent communication and collaboration skills Strong stakeholder management and influencing skills Experience in use of quality systems and/or change management To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
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.
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.

---