Our client, a pharmaceutical company in the LA area is looking for a Compliance Manager to join their team!
- The Compliance Manager implements, maintains and continually improves the compliance function at the company.
- The Compliance Manager provides substantial input and oversight into a variety of projects and processes to insure adherence with all laws, regulations and contractual obligations that apply.
- Acts as an advisor on custom software development projects and Commercial Off-The-Shelf Software (COTS) to ensure regulatory compliance.
- Collaborates with Quality Assurance and other departments as advisor on compliance issues for resolution.
- This position serves as the main interface with sponsor and regulatory auditors/inspectors.
- Responsible for staffing, scheduling, interviewing and hiring, evaluating work performance, counseling, discipline, and termination. Participates in addressing employee grievances.
- Provides daily direction, communication, training, and oversight to the team to ensure efficient productivity.
- Monitors and negotiates the scope of the compliance work and commitments.
- Monitors workflow to ensure adequate productivity and timely completion of projects. Notifies appropriate personnel of delays or problems which may affect timelines and/or deadlines.
- Oversee study assignments and resourcing in conjunction with appropriate stakeholders.
- Aids in the development of training programs for existing staff and new hires.
- Mentors team personnel, including but not limited to:
- Establishing timelines/expectations for training of individuals, and monitoring progress.
- Identifying training and learning opportunities for compliance team (e.g. technical training, educational programs, quality improvement projects), and involving or delegating to direct reports accordingly.
- Inviting team members to participate in meetings or teleconferences, both internal and external (e.g. setting up a study)
- Providing feedback for circumstances as observed on a day-to-day basis
- Including team members in quality improvement and/or other ad hoc projects
- Knowledge and information sharing
- Oversees and provides direction for regulatory compliance strategy and activities
- Stay up-to-date with the latest developments in regulatory compliance, in particular as relates to the company.
- Maintains an expert level understanding of any and all laws, regulations and contractual obligations that apply to the company.
- Act as the primary point of contact for external regulatory compliance audits from sponsors and regulatory agencies and is responsible for related inspection readiness activities at company.
- Prepare responses to external compliance audit observations, and works in coordination and collaboration with impacted stakeholders to address audit findings and in accordance with internal procedures/policies.
- Bachelor’s degree required. Combined education and experience may be used as substitute for minimum
- Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research
- Certified Regulatory Compliance Manager (CRCM) preferred.
- CCRP or similar clinical research certification beneficial.
- 5 years of progressive management experience.
- Prior supervisory experience preferred
- Strong familiarity with CFR Title 21, ICH GCP, and GDPR
- Experience with ISO9001 beneficial
- 5+ years developing and implementing compliance programs in a laboratory or healthcare environment.
- Project management experience preferred
- Minimum of 4 years of progressively responsible professional experience required.
- Experience in multi-center clinical trials required.
- Familiarity with process and quality improvement principles (e.g. Six Sigma) preferred.
- 5+ years working in a clinical research environment
- Familiarity with software development and the software development lifecycle
- Expert level in standard Microsoft Office programs