Director of Compliance
Proclinical is seeking a Director of Compliance for a cutting-edge medical clinic located in Miami, FL.
The Compliance Director provides a leadership role in managing, overseeing, and coordinating all aspects of Compliance department, in accordance with Good Clinical Practice (GCP) and Federal Regulations. This person will ensure the company adheres to legal standards and in-house policies and will be responsible for enforcing regulations in all aspects and levels of business as provides guidance on compliance matters to preserve trial integrity by making sure it stays on a lawful and ethical course.
Must be eligible to work in the US.
- SOP writing.
- CAPA writing.
- Host sponsor and FDA audits.
- DEA initial submissions and continued monitoring/ interfacing with the Business Development team to ensure timely updates.
- Understand and stay current on State and Federal regulations.
- Strategically assign QC staff to sites based on business needs.
- Train QC staff on good communication with sponsors.
- Develop and oversee control systems to prevent or respond to violations of legal guidance and internal policies.
- Ensure all Compliance staff adheres to establish Standard Operating Procedures (SOPs) when performing Quality Control reviews.
- Perform annual performance appraisals, setting annual goals and plans for each direct report.
- Meet regularly with each direct report throughout the year to discuss progress on goals.
- Provide timely feedback, including objective, measurable goals, for any areas of improvement.
- Evaluate the efficiency of Quality controls and improve them continuously.
- Revise procedures, reports, etc. periodically to identify hidden risks on non-conformity issues.
- Create, implement, and maintain Quality Control processes.
- Review and approve (as necessary) SOPs for use in protocols, protocol amendments, Investigator Brochures, and other project/study related documents.
- Create, implement, and maintain Quality Document Control processes.
- Oversee the review and approval of investigators and violations affecting Development and Operations Activities and approves corrective actions recommendations and final conclusions.
- Develop, implement, and manage assessments and reviews and other oversight activities (such as monitoring quality and compliance metrics) to ensure compliance with standards of quality.
- Develop, implement and manage the Quality and Compliance issues reporting process.
- Collaborate with corporate counsels and HR department to monitor enforcement of standards and regulations.
- Review the work of colleagues, when necessary, to identify compliance issues and provide advice and/or training.
- Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
- Act as an expert advisory/consultant to operational teams on matters of compliance and quality issue management, ensuring consistent quality standards and fostering strong working relationships.
- Prepare reports for executive management and external regulatory bodies as appropriate
- Evaluate departmental processes and recommend improvements with goals or regulatory compliance, increased efficiency, improved product/service quality, and process automation.
- Provide routine training to staff to develop skills to related GLP, GDP, and GCP compliance issues.
- Coach, develop, and serve as a resource to direct reports for their career path.
- Reports critical and major concerns to President and Medical Director.
- Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.
- Create an escalation strategy focused on priorities as dictated by President and Medical Director.
- Always remain solutions oriented.
Skills and Requirements:
- Work closely with department to ensure adherence to protocols, SOPs, and regulations/guidelines.
- Supervise Independent Quality Control Contractors as necessary.
- Customer Focus-Understanding the needs of the internal or external customer and keeping them in mind when taking actions or making decisions.
- Develop and maintain excellent working relationship with internal and external associated to assure adequate and compliant us of investigational product.
- Team Player-effective participant as a team member-Can demonstrate significant positive participation on successful teams.
- Team Leader-Effective leadership skills- Can lead by example while also serving as a mentor
- Practices professionalism and integrity in all actions-Demonstrates cooperation, self-control, discretion and flexibility to get the work done.
- Problem solving techniques-Able to adapt to a changing environment and demonstrate a "make it happen" attitude. Exhibits professionalism in negotiating sensitive issues.
- Interpersonal Interaction-Demonstrates excellent people skills and a positive attitude.
- Excellent verbal, written communication and presentation skills
- Strong organizational skills-Ability to prioritize and to manage multiple tasks as necessary
- Attention to detail-Produces high quality, accurate work with minimal oversight
- Functions well under high-pressure conditions.
- Bachelor's degree required, preferable in a biopharmaceutical/healthcare industry or related field.
- Minimum 5 years' experience working in Clinical Research or related field.
- Minimum 5 years' experience working in Quality Assurance, or Quality Control or Compliance experience supporting GCP, GDP, GMP, GLP.
- Knowledge of Project Management.
- Clinical Research certifications (CCRP, GCP, GCLP) a plus
- Familiarity with ISO 9000 standards and implementation, ICH Guidelines, Title 21 Code of Federal Regulations a must.
- Knowledge of industry regulations: HIPAA, OSHA, GCP, GDP, CRF, and ICH Guidelines
- Some travel-Not more than 20%
If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at +(1) 617-830-1627 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.