Clinical QA Manager

Job Description
Mission
The Clinical QA Manager will be responsible for the development, maintenance and oversight of the GCP activities related to clinical trials sponsored by AGTC. This involves working closely with CDO (Clinical Development Operations), Information Technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities. Provides Quality oversight of internal and external clinical trial activities, related records, and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations and assists with tasks necessary to achieve department and/or company goals.

Description:
Reporting Relationship                                                                                                                                                              
  • •The Clinical QA Manager will report directly to the Executive Director, Quality Assurance or designee
Duties and Responsibilities
  • Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures
  • Develops and maintains GCP/ICH compliant processes which control the quality of work and clinical trials conducted at AGTC
  • Responsible for the establishment and leadership of the Inspection and Audit Readiness program
  • Collaborates with CDO, CRO vendors, and clinical investigator sites to provide QA support and oversight while assessing compliance with local regulations, GCP/ICH requirements, clinical study protocols and SOPs
  • Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts
  • Conduct Clinical Study Report (CSR) and Trial Master File (TMF) audits
  • Communicates Investigator Site and Clinical Vendor audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
  • Evaluate audit observation trends and escalate as required to applicable functional leads
  • Maintains databases for Investigator Site audit observations and CAPAs; Tracks, reviews, approves, and assesses the adequacy of CAPAs. Provides input and supports observation and CAPA tracking for external Clinical vendors.
  • Participates in the evaluation and qualification of CROs and other clinical vendors in compliance with AGTC SOPs
  • Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to the appropriate stakeholder(s)
  • Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable
  • Performs program-specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
  • Lead/support continuous improvement activities and conduct internal training on Clinical Quality standards and regulations
  • Attends cross-functional team meetings and provides guidance to functional stakeholders based on interpretation of current regulations to ensure best practices
  • Conducts internal audits (systems, processes, vendors, computer system validation)
  • Conducts reviews of clinical, regulatory, and other applicable documents, ensuring quality, accuracy, and completeness. May conduct quality assurance review/audit of protocols, Clinical Study Reports, Investigator Brochures, and Integrated Summaries, etc.
  • Supports the CDO team with the preparation, coordination, and management of regulatory agency inspections
  • Reviews and updates AGTC SOPs, identifying the need for new SOPs, and developing new CQA SOPs as needed
  • Shares responsibility with the team for the development of training materials and conducting training
  • Works with Clinical staff to investigate temperature excursions, product complaints and deviations reported from clinical sites
  • Participate in the budget planning process for Quality Assurance
  • Identify and address GCP compliance issues across AGTC clinical systems and processes to strengthen their Quality and ensure a state of readiness for regulatory inspections
  • Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization
  • Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP, and communicate these to the QA team and QA management, as applicable
  • All other duties as assigned
Educational Qualifications
  •  BS degree required, preferably in a scientific field
Additional Qualifications
  • Minimum of at least five (5) years of clinical quality assurance experience, of which at least three (3) years clinical auditing/oversight experience in the regulatory compliance environment or an equivalent combination of education and experience
  • Experience in supervising, mentoring or coaching others preferred
  • Excellent communication and negotiation skills; maintains high ethical standards, and enjoy working with people and information, making decisions, problem-solving, making a difference and working in a leadership role
  • Adheres to ethical and good clinical practices and the ability to work as part of a team, as well as work independently in a remote workforce environment
  • Excellent organizational skills and ability to work on multiple projects with competitive timelines is required
  • Strong attention to detail and respect for the need of accuracy of information
  • Exceptional verbal, written, and interpersonal communication and presentation skills
  • Must be capable and willing to travel (25% - 50%), including the potential for international travel
  • Must have a thorough understanding of applicable US and international GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits
  • Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project)
  • Demonstrated ability to work effectively in cross-functional team environment
  • Excellent problem-solving and decision-making skills
  • Stays current with changes to current GCP/GLP/GCLP regulations, guidance, safety reporting including FDA, EU, and other regulatory bodies
  • Expertise in Good Clinical Practice (GCP) environment, which includes working in a QA role supporting GCP compliance
  • Proficient knowledge of ICH, GCP, and applicable CFRs, guidance documents, systems processes and procedures
  • Experience in clinical operations and handling trial essential documents is preferred
  • Additional experience conducting GLP and/or GMP audits a plus
  • Great attention to detail
  • Strong interpersonal skills
  • Effective communication skills both verbally and written
  • Proven ability to manage complex projects
Physical Requirements
  • Physical demands:
            ☐ sedentary (< 10 lbs.)
            ☒ light work (< 20 lbs.)
            ☐ medium work (< 50 lbs.)
            ☐ heavy work (< 100 lbs.)
            ☐ very heavy work (> 100 bs.)
  • Physical activity:
            ☒repetitive motion
            ☒ balancing
            ☐stooping
            ☒lifting
            ☐climbing
            ☐kneeling/crouching
            ☐crawling
            ☒reaching
            ☒standing
            ☒ typing/grasping
            ☒walking
             ☒pushing/pulling
            ☒hearing
  • Visual acuity: preparing/analyzing data, transcribing, and reading
  • Working conditions: indoor office environment and laboratory facilities. Low noise levels
Supervisor Responsibilities
  • This position has supervisory responsibilities
Contact Information