Job Description:A Regulatory
Compliance Consultant supports Oracle Life Sciences Global ISO certifications; as well as: Adherence to pharmacovigilance (adverse event reporting), data privacy (state and federal level), industry (GCP, GEP, GPP and GVP), internal (vendor management and training), pharmaceutical clients, and other regulatory (FDA and HIPAA) requirements. This position will report to the Senior Global
Quality and Compliance Manager.Career Level - N/A
Responsibilities:- Responsible for implementing established quality processes & ensuring adequate application among Asia/Pacific teams
- Responsible for ensuring that all projects are conducted in accordance with Oracle Life Sciences SOPs
- Perform internal and external auditing based on Oracle Life Science's quality system standards; for example, ISO 9001:2015, ISO 20252:2019, PV, FDA readiness audits
- Responsible for ensuring compliance with pharmacovigilance requirements
- Communicate team, or domain level, goals that support and advance team, domain level, and/or organizational compliance objectives; monitor metrics, or other performance measures, to track progress against established goals
- Influence diverse stakeholder groups and drive acceptance of policies, practices and procedures within broader area of responsibility
- Identify, propose, and support team- and domain level, Quality and process improvement initiatives; lead or influence strategic initiatives at the domain level and provide input on strategic initiatives for the organization
- Assist with training, guidance and feedback to encourage success and promote associate growth through regular domain developmental conversations and identification of domain developmental opportunities
- Maintain Quality and Compliance documentation- e.g. SOPs, templates, working instructions
- Organize and deliver trainings from clients and/or industry guideline trainings internally to Associates and externally to our vendors
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