We are representing a growing National Product Stewardship Program in their search for a Senior Compliance Advisor for their California Operations.
Why Join Us:
- Work with an organization developing and implementing compliant, efficient and effective community-level pharmaceutical product stewardship take back programs for unwanted pharmaceutical products
Expectations first 12 months:
- Independently manage California operations and implement compliance programs for all California operations
- Design, implement, and evaluate internal controls for assigned aspects by translating regulatory and business requirements into policies, processes, procedures, plans and reports
- Develop and implement routine compliance program key performance indicators and identify program improvements
Principal Responsibilities
- Provide consultation and training to the business regarding conformance to business policy and procedures, best practices, interpretation of regulatory requirements, and regulatory communications
- Support all stages of written product stewardship plan development and maintenance, including responding to regulatory inquiries and liaison with California regulatory staff
- Ensures that all appropriate local, state, and federal regulations are followed and provides consultative services to internal staff
- Coordinate periodic producer list compliance reporting
- Support annual reporting for Program, including developing and ensuring systems are in place to provide verifiable data for submission to the regulators
- Coordinate with operations on incident management, audit, and surveillance programs
- Take a lead position owning compliance matters of the California operations and will contribute to the program’s overall objectives by implementing compliance strategies
- Design, implement, and evaluate internal controls for assigned aspects by translating regulatory and business requirements into policies, processes, procedures, plans and reports.
- Project scopes may include operations, communications, inspections, financial, and code of conduct related aspects
Qualifications:
- Experience translating regulatory requirements into policies, processes, procedures, plans and reports
- Experience designing, implementing, and evaluating internal controls; leading root cause analysis using various methodologies
- Demonstrated experience leading incident investigation, leading corrective and preventative action management systems
- Experience with unwanted medicine reverse distribution
- Experience working in highly regulated environment and interacting with California state regulators
- Experience writing and implementing operating procedures and creating and delivering training
- Experience managing multiple stakeholders
- Comfortable in a fast-paced environment and able to manage multiple projects
- Exceptional problem-solving capabilities and resourceful under pressure
- Ability to work in a team environment with ability to influence others to create a positive working environment in a virtual environment (virtual tools and travel)
- Applicable professional degree in Law, Business, Engineering, or other technical degree; or a minimum of 15 years applicable professional experience
Relocation Policy:
No relocation package offered.
Application Process- Qualified professionals are to submit resume to Jessica Simpson at: j essica@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
