Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
About the role
- Senior Compliance Lead at Boeing overseeing compliance in the BDS Sapphire program. Driving strategy, managing cross-functional projects, and ensuring compliance across multiple risk domains.
Responsibilities
- Set the strategy, approach, and roadmap for addressing compliance requirements across the BDS Sapphire program
- Identify applicable compliance requirements across key risk domains and translate them into program-level objectives and actionable requirements
- Ensure compliance requirements into solution design, development, testing, and deployment activities.
- Ensure end-to-end requirements traceability
- Coordinate, manage, and track compliance efforts across IPTs
- Maintain a single source of truth for compliance status, gaps, and remediation plans
- Facilitate engagement of compliance Subject Matter Experts (SMEs) across BDS and IDT&S
- Coordinate escalations and decision paths for compliance risk resolution
- Identify and coordinate remediation of downstream compliance impacts
- Ensure compliance readiness across IPTs and facilitate population pulls, define and monitor KPIs, and prepare artifacts
- Support preparation of evidence packages and corrective action plans as needed
- Monitor and report compliance risks, milestones, and remediation progress to program leadership
- Recommend and implement continuous improvement actions
Requirements
- Bachelor’s degree or higher
- 5+ years of experience in a compliance related role
- 5+ years of experience leading or managing projects that involved cross-functional or cross-business unit teams
- Experience using excellent verbal and written communication skills to communicate with leaders and colleagues
- Experience with Defense Federal Acquisition Regulation (DFAR) on Material Management and Accounting System requirements as well as general CAS and FAR regulations
- Experience identifying key stakeholder project specific requirements and scope, then building and managing project plans
- Experience identifying and managing risk
Benefits
- health insurance
- flexible spending accounts
- health savings accounts
- retirement savings plans
- life and disability insurance programs
- paid and unpaid time away from work
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