About Company:
Evolution Research Group (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 United States and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed more than 5,000 trials and continues to expand into high-need therapeutic areas in the United States and globally.
At ERG, team members contribute to meaningful research in a collaborative, mission-driven environment. We offer competitive benefits, including medical and dental coverage, a matching 401(k), paid time off, and the opportunity to work alongside experienced clinical research professionals and industry leaders.
Position SummaryThe Quality Assurance Director will be based onsite at Clinical Pharmacology of Miami (CPMI), ERG’s largest clinical research site. This leadership role is responsible for ensuring that day-to-day clinical trial operations are conducted in accordance with study protocols, FDA regulations, ICH/GCP guidelines, applicable requirements, and ERG standard operating procedures.
The Director provides essential quality oversight, reporting to the Vice President of Quality Assurance, while working in direct collaboration with Operational Leadership. The successful candidate will bring strong technical expertise, sound judgment, exceptional organization, and the ability to mentor and lead others in a fast-paced, high-volume clinical research environment.
Key Responsibilities may Include but is Not Limited to:- Audit Management: Plan, prepare for, host, support, and close internal, external, sponsor, regulatory, and vendor audits, including oversight of responses, action items, deliverables, and follow-up activities.
- Risk Mitigation and CAPA Oversight: Lead quality events, investigations, risk assessments, containment activities, corrective and preventive actions, and effectiveness checks from initiation through closure.
- Training and Staff Development: Oversee training metrics, deliver quality-related training, mentor site staff on regulations and guidelines, and support Operations in developing consistent training modules aligned with clinical site and corporate processes.
- Quality Control Oversight: Ensure meaningful Quality Control plans are implemented, monitored, and aligned with areas of risk, client commitments, quality trends, and potential vulnerabilities.
- Document Control: Oversee, manage, and review document creation, revision, obsoletion, and related change activities while identifying opportunities for alignment across ERG portfolios.
- Quality Communication: Serve as a primary point of contact for CPMI quality-related actions, and for ERG quality matters when delegated, ensuring professional communication, timely responses, clear deadlines, and effective coordination of deliverables.
- Leadership and Mentorship: Provide guidance, coaching, and mentorship to site staff and direct reports while aligning with Operational Leadership and the Vice President of Quality Assurance on messaging, decision-making, and quality priorities.
- Computer System Validation: Support companywide computer system validation initiatives and testing requirements governed under 21 CFR Part 11, as applicable.
- Project Management and Process Optimization: Lead or support projects that advance leadership initiatives, process optimization, implementation planning, and operational rollout activities.
- Early Phase Portfolio Oversight: Provide quality oversight and support to ERG portfolio sites, specifically Ohio Clinical Trials, as aligned with clinical trial expectations and assigned responsibilities.
- Additional Responsibilities: Perform other duties as assigned by the Vice President of Quality Assurance.
While the position is primarily based at CPMI, the Quality Assurance Director is also part of ERG’s Corporate Quality Assurance Team, which provides support across ERG portfolio sites. Responsibilities may include assisting with the overall Quality Management System, quality assurance, quality control, compliance, audit readiness, regulatory inspection support, and study conduct oversight across additional sites as needed..
As needed, or in the absence of the Vice President of Quality Assurance, this role may assume leadership of the ERG Corporate Quality Assurance Team and oversee the planning, execution, and analysis of quality assurance initiatives. Potential travel to other ERG portfolio sites may be required to support QA initiatives, audits, regulatory inspections, or other support, etc as applicable and assigned.
QualificationsThe ideal candidate will demonstrate strong technical knowledge, leadership capability, sound judgment, and a practical understanding of clinical research.
- Bachelor’s degree or higher in life sciences, medicine, or a related field, or equivalent experience.
- Minimum of 10 years of experience in a Quality Assurance role within clinical research; pharmaceutical or medical device industry experience may be considered.
- Thorough understanding and practical application of ICH/GCP, FDA regulations, HHS regulations, namely HIPAA, and other regulations applicable to clinical research in the United States.
- Experience participating in FDA inspections or other regulatory agency inspections.
- Extensive experience managing CAPA programs with a focus on GCP compliance, timely completion, and quality deliverables.
- Background in project management, site leadership, or oversight of high-volume clinical trials strongly preferred.
- Experience with 21 CFR Part 11 and aspects of Computer System Validation preferred.
- Bilingual Spanish proficiency highly preferred.
- Strong knowledge of medical terminology.
- Exceptional organizational and prioritization skills, with the ability to manage multiple critical priorities in a dynamic, fast-paced, high-volume environment.
- Strong analytical, problem-solving, and critical-thinking abilities.
- Ability to provide accurate guidance and practical support regarding regulatory requirements and their application.
- Excellent documentation practices and strong attention to detail.
- Exceptional interpersonal, written, and verbal communication skills.
- Proficiency with Microsoft 365 and familiarity with clinical research systems, including Clinical Trial Management Systems.
- Ability to travel as requested by the Vice President of Quality Assurance.
This position reports to the Vice President of Quality Assurance and works closely with CPMI Operational Leadership, site staff, corporate Quality Assurance colleagues, sponsors, vendors, and other internal and external stakeholders.
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Evolution Research Group Edison, New Jersey, USA Office
Edison, New Jersey, United States, 08837
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