Quality Assurance and Compliance Director

Job Description

Job Description

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 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. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description:

The Quality Assurance and Compliance Director ensures that all clinical trials are conducted in accordance with study protocols, FDA regulations, and ICH/GCP guidelines by way of internal audits, oversight of training, and the maintenance of all Quality driven activities at the clinic. This position is also part of the Quality Mobile Unit (QMU) which requires assistance and support of the overall Quality Management System for ERG to promote quality assurance, quality control, compliance, and auditing activities as they relate to conduct of studies or vendor management. As needed or in the absence of the Vice President of QA, lead the Quality Mobile Unit (QMU) team in plan, execution, and analysis of Quality Assurance initiatives as well as external audits for the organization, with direct report to the Vice President, QA. In executing these position responsibilities, the Director, Quality Assurance is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities:

QUALITY MANAGEMENT OF CLINIC

• Conduct audits of study documents, Case Report Forms, Informed Consent Forms, and Clinical Study Reports to assure 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 site’s QA Audit Plan
• Report significant Quality issues to Vice President, Quality Assurance
• Evaluate results of System and Data Audits and oversees the implementation of corrective actions with input and support by Site Director and Vice President, QA
• Responsible to facilitate Sponsor Audits and assist with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA)
• Assist with supporting FDA Inspections and preparation activities.
• Oversee training is conducted in accordance with SOPs and records are sufficiently maintained and up to date.
• Responsible for facilitating in conjunction with Vice President QA, Corrective and Preventive Actions (CAPA) and conducting effectiveness checks as applicable.
• Perform any other duties as assigned by Vice President, QA in collaboration with Site Director, as applicable.
• Responsible for communicating site trends to QMU Team and Site Director.

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) 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.
• Active travel to all site clinics to assist with QA initiatives, Corrective actions, training of staff, study preparations or sponsor meetings, as applicable.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience
  • Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR) as they apply to clinical research.
  • Bachelor’s degree preferred, or equivalent in experience.
  • 10 or more years relevant experience in pharmaceutical, clinical, or medical device industry, inclusive of performance of internal and external audits
  • At least 5 years’ experience participating in inspections by the United States Food and Drug Administration, or other compliance agencies preferred.
• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Demonstrate strong analytical and problem-solving skills.
  • Strong commitment to team-based organization and collaboration
  • Ability to organize and prioritize within a changing environment.
  • Able to appropriately advise and assist with guidance and regulatory requirements.
  • Excellent documentation practices
  • Attentive to detail, good initiative and able to work with changing priorities.
  • Ability to travel upon request of VP of QA
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)