Compliance Manager

Location
90033, Los Angeles
Salary
$80K-$90K
Posted
Mar 12, 2019
Required Education
Bachelors Degree
Position Type
Full time

Our client, a pharmaceutical company in the LA area is looking for a Compliance Manager to join their team! 

Summary:

  • 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.

Responsibilities:

  • 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.

Qualifications:

  • Bachelor’s degree required. Combined education and experience may be used as substitute for minimum
    education.
  • Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research
    preferred.
  • 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