Location: Miami (Onsite)

Job Description:

This role is based at our largest site, Clinical Pharmacology of Miami (CPMI). The Director's primary role is for 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. This 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.

Oversight and communication with the Operational Team may include (but is not limited to):

• Conducting internal audits
• Monitoring training completion and associated metrics
• Providing support and consultation for Quality events and CAPAs
• Overseeing and assisting with internal and external audits
• Managing and supervising Quality Control plans and QC staff
• Maintaining all Quality-related activities within the clinic

Additionally, this role is part of the ERG Corporate Quality Assurance Team, a mobile unit that provides coverage across all ERG portfolio sites. Responsibilities include supporting the overall Quality Management System for these sites to ensure quality assurance, quality control, compliance, and auditing activities related to study conduct.

As needed, or in the absence of the Vice President of Quality Assurance, this role may assume leadership of the ERG Corporate QA Team, oversee the planning, execution, and analysis of Quality Assurance initiatives, as well as managing external audits for the organization. This position reports directly to the Vice President of QA.

In fulfilling these responsibilities, 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.

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
• Responsible for facilitating Sponsor Audits and assisting with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA)
• Assist with supporting Regulatory (FDA, EMA, etc) Inspections and preparation activities
• Oversee training is conducted in accordance with SOPs and reports metrics to Operational Leadership for required management and next steps.
• Responsible to 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.
• Responsible to 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, professionalism, and alignment with Operational Leadership and the Quality Assurance Department.
• Supervise direct reports supporting Quality Assurance and Quality Control efforts on clinical trials.

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 ERGs Quality Management System (QMS), inclusive of the eQMS, to ensure compliance to Good Clinical Practice (GCP) and that the QMS is aligned with the internal policies and standard operating procedures for ERG.
• 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 Corrective and Preventive Actions (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.

Skills and Qualifications:

• 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).
• Bilingual Spanish highly preferred
• 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 International Conference on Harmonization (ICH) guidelines.
• Knowledge of medical terminology.
• 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.
• 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).