The Sr. Director, Regulatory Compliance, provides strategic direction and leadership to Rho.
Driving the overall effectiveness and change management of Rho’s Quality Management Systems utilizing deep knowledge and expertise in Global Regulatory requirements
Providing Rho’s senior executives, project teams and clients with strategic regulatory input and technical guidance on regulatory requirements and impact to business processes; including monitoring changing regulations and impacts to Rho’s procedural documents and business processes and implementing appropriate changes
Providing expertise and guidance to Rho’s senior management on the implications of ICH/GCP and other applicable regulations to business processes
Providing leadership to compliance-related corporate strategic initiatives
Recommending and implementing risk mitigation strategies related to identified compliance issues, andensuring timely resolution of issues identified
Identifying future risks and provision of solutions before risks become a barrier to operations
Oversight of the Quality Assurance team including senior QA personnel and auditors while creating strong working relationships with Organizational Development and operational leadership including providing strategic guidance for inspections, audits and CAPA systems
BA/BS in life sciences, social sciences, liberal arts or a related degree and at least 10 years of increasingly responsible experience in clinical (GCP) quality assurance and regulatory compliance, advanced degree preferred.
Prior QA and Regulatory Compliance experience supporting professional services within the biotechnology or pharmaceutical industry is required.
Certification in clinical research, regulatory affairs, or auditing (CCRP, RAC, etc.) preferred.
Integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment
Excellent organizational and communication skills with strong track record in negotiations and problem-solving, able to work independently as well as a member of a multiple level team
Understanding of CROs, health sciences terminology and the drug/device development process
Knowledge of and experience with applicable global regulatory requirements including ICH/GCP and 21 CFR.
Understanding of business concepts and experience in using strategic processes to make good business recommendations and decisions
Strong business acumen; excellent written and verbal communication skills; and strong Excel, Word, and PowerPoint skills.