Job Summary
This role involves the implementation of data governance standards, policies and procedures into business operations. You will be a site resource and subject matter expert on good DG practices, ensuring Business Groups align with the IOPS Data Governance Program.
Key Responsibilities
* Implementation of standards, policies and procedures within allocated areas of the business
* Provide support and advice to allocated business areas as key DG contact
* Engage with allocated business units on DG priorities and action plans
* Assess current policies and processes in allocated business units, overseeing achievement of local DG KPIs
* Conduct regular data audits and assessments to identify DG issues, working with business areas to prepare for DG auditing and inspections
Requirements
* 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
Qualifications
* Bachelor's degree or equivalent in a relevant field
* At least 7 years of professional experience in pharmaceutical/FDA regulated work areas, such as data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT
About Us
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, military or veteran status, or any other protected characteristic.