We are currently looking to fill a Principal GMP Data Governance Business Partner role. This role is responsible for the implementation of data governance standards, policies, and procedures into business operations. This position serves as a site resource and subject matter authority on good data governance (DG) practices. This position ensures Business Groups are aligned to the IOPS Data Governance Program. This position supports the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program.
As a Principal GMP Data Governance Business Partner, a typical day might include the following:
Implementation of standards, policies, and procedures within allocated areas of the businessBe the allocated business area(s) key DG contact providing support and advice where vitalEngage with the allocated business unit on DG priorities, action plansAssess allocated business unit's current policies and processes and be responsible for the achievement of local DG meaningful metricsConduct regular data audits and assessments to identify DG issuesWork with allocated business area to prepare for DG auditing and inspectionsSee opportunities to improve data-related processes, systems and tools within allocated business area that are aligned with the business's evolving needs and industry standard processesWork in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and feedback themes to allow CI & evolution of the DG approachFeedback themes to Data Governance Leadership team to allow CI & evolution of the data governance approachStaying updated on the latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPSEncouraging a culture of quality & DG within the organizationPromoting the importance of DG across all departmentsDriving communication and partnership between collaborators to ensure effective DG practicesEncouraging CI by actively seeking feedback and supporting initiatives crafted to improve data quality and governanceLeading/supporting initiatives to embed DG principles into the company's core values and everyday practicesThis role might be for you if:
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 IntegrityProven success in implementing and leading policies and standards within a regulated environmentThe ability to collaborate with other DG Business Partners, ECM Experts, Technical Experts, and cross-functional teams & excellent social skillsExperience of working in a cGMP & GDP environmentStrong partner management and influencing skillsTo be considered for this role you must hold a Bachelor's and the following minimum amounts of relevant professional experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT for each level:
Principal—8+ yearsStaff—10+ yearsCertification in data governance or data management preferred. Experience in use of quality systems and/or change management preferred. May substitute shown experience for education requirement. Level is determined based on qualifications relevant to the role.
#REGNQADoes 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.
Salary Range (annually) $89,100.00 - $170,100.00
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