Director of Quality Assurance and Compliance
American Society for Clinical Pharmacology and Therapeutics, Miami, Florida, us, 33222
Overview
Job Title: Quality Assurance and Compliance Director
CPMI (Miami) based. The primary role is ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines. The role provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities. This is a leadership role and the ideal candidate will have experience mentoring and leading others. The CPMI-based Quality Assurance and Compliance Director operates in alignment with FDA regulations, Good Clinical Practice (GCP) guidelines, and the company’s standard operating procedures and policies.
About Evolution Research Group (ERG): ERG is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. We offer competitive benefits including medical and dental coverage, a matching 401(k), and paid time off.
Responsibilities
Quality Management of the Clinic
Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance
Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively
Conduct GCP compliance audits of vendors in accordance with Standard Operating Procedures
Report significant Quality issues to Vice President, Quality Assurance
Oversee the implementation of corrective actions with support of the Site Director and VP of Quality
Facilitate Sponsor Audits and assist with other Sponsor site visits as applicable (and report results of audits to Vice President, QA)
Assist with supporting Regulatory (FDA, EMA, etc.) inspections and preparation activities
Oversee training conducted in accordance with SOPs and report metrics to Operational Leadership for required management and next steps
Oversee all Document Control activities for the site, and for other sites as requested from the VP of QA
Ensure the appropriateness and effectiveness of site CAPA investigations and oversee timely and accurate reporting of results to applicable stakeholders, including Sponsors, CROs, and IRBs
Fully manage all aspects of the electronic Quality Management System as it applies to CPMI (and to ERG as a whole under the direction of the VP of Quality)
Play a key role in site leadership and client engagement, ensuring clear communication and alignment with Operational Leadership and the Quality Assurance Department
Supervise direct reports supporting Quality Assurance and Quality Control efforts on clinical trials
Perform additional duties as assigned by the Vice President of QA in collaboration with the Site Director
ERG Corporate QA Team (Quality Mobile Unit)
Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities. Assist in maintaining ERG’s Quality Management System (QMS), inclusive of the eQMS, to ensure compliance to GCP and alignment with internal policies and SOPs. Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections. Participate in the oversight of CAPA implementation and assist in conducting Quality reviews. Perform any other tasks/duties assigned by VP QA. Potential travel to other ERG portfolio sites to assist with QA initiatives, internal audits, regulatory inspection support, etc., as applicable and assigned. This role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization.
Education and Experience
Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research.
Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience).
Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits.
At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred).
Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables.
Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired.
Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required).
Requirements
Strong understanding of FDA regulatory requirements, Good Clinical Practice (GCP), and ICH guidelines.
Knowledge of medical terminology.
Demonstrated commitment to a collaborative, team-oriented environment.
Excellent organizational and prioritization skills with the ability to adapt in a dynamic, changing environment.
Strong analytical and problem-solving abilities.
Ability to provide accurate guidance and support on regulatory requirements.
Excellent documentation practices and attention to detail.
Proactive, with good initiative and ability to manage shifting priorities.
Ability to travel as requested by the Vice President of QA.
Exceptional communication skills (interpersonal, written, and verbal).
Proficiency in computer applications, including Microsoft Word and Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems).
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About Evolution Research Group (ERG): ERG is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. We offer competitive benefits including medical and dental coverage, a matching 401(k), and paid time off.
Responsibilities
Quality Management of the Clinic
Lead and conduct audits of study documents, Case Report Forms, Clinical Study Reports, and other supporting documentation to ensure compliance
Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively
Conduct GCP compliance audits of vendors in accordance with Standard Operating Procedures
Report significant Quality issues to Vice President, Quality Assurance
Oversee the implementation of corrective actions with support of the Site Director and VP of Quality
Facilitate Sponsor Audits and assist with other Sponsor site visits as applicable (and report results of audits to Vice President, QA)
Assist with supporting Regulatory (FDA, EMA, etc.) inspections and preparation activities
Oversee training conducted in accordance with SOPs and report metrics to Operational Leadership for required management and next steps
Oversee all Document Control activities for the site, and for other sites as requested from the VP of QA
Ensure the appropriateness and effectiveness of site CAPA investigations and oversee timely and accurate reporting of results to applicable stakeholders, including Sponsors, CROs, and IRBs
Fully manage all aspects of the electronic Quality Management System as it applies to CPMI (and to ERG as a whole under the direction of the VP of Quality)
Play a key role in site leadership and client engagement, ensuring clear communication and alignment with Operational Leadership and the Quality Assurance Department
Supervise direct reports supporting Quality Assurance and Quality Control efforts on clinical trials
Perform additional duties as assigned by the Vice President of QA in collaboration with the Site Director
ERG Corporate QA Team (Quality Mobile Unit)
Member of a professional team focused on clinical quality assurance/quality control and compliance-related activities in support of clinical programs and activities. Assist in maintaining ERG’s Quality Management System (QMS), inclusive of the eQMS, to ensure compliance to GCP and alignment with internal policies and SOPs. Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections. Participate in the oversight of CAPA implementation and assist in conducting Quality reviews. Perform any other tasks/duties assigned by VP QA. Potential travel to other ERG portfolio sites to assist with QA initiatives, internal audits, regulatory inspection support, etc., as applicable and assigned. This role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization.
Education and Experience
Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research.
Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience).
Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits.
At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred).
Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables.
Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired.
Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required).
Requirements
Strong understanding of FDA regulatory requirements, Good Clinical Practice (GCP), and ICH guidelines.
Knowledge of medical terminology.
Demonstrated commitment to a collaborative, team-oriented environment.
Excellent organizational and prioritization skills with the ability to adapt in a dynamic, changing environment.
Strong analytical and problem-solving abilities.
Ability to provide accurate guidance and support on regulatory requirements.
Excellent documentation practices and attention to detail.
Proactive, with good initiative and ability to manage shifting priorities.
Ability to travel as requested by the Vice President of QA.
Exceptional communication skills (interpersonal, written, and verbal).
Proficiency in computer applications, including Microsoft Word and Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems).
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