Manager Clinical QA
Location: London, UK
Reporting to: Director, GCP Quality Assurance.
The Clinical QA Manager will be responsible for the development, maintenance, and oversight of the GCP activities related to clinical trials sponsored by Orchard Therapeutics. This involves working closely with Clinical Operations, 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.
- Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures.
- Coach and Business stakeholders by providing leadership, expert advice, support and management for translating the Quality strategy into operations.
- Contribute to preferred CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process.
- Drive and ensure continuous alignment on the clinical development quality ways of working across the different projects/clinical trials through engaging with key stakeholders and functional teams.
- Collaborates with Clinical Operations, Clinical Research Organizations (CRO), vendors, and Clinical Investigator sites to provide QA support and oversight while assessing compliance with local regulations, CFRs & 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.
- 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.
- Maintains databases for Investigator Site audit observations and CAPAs. Tracks, reviews, approves, and assesses the adequacy of CAPAs.
- Collaborate with Compliance QA on tracking vendor audits and CAPA tracking for external Clinical vendors.
- 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 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.
- Attends cross-functional team meetings and provides guidance to functional stakeholders based on interpretation of current regulations to ensure best practices.
- 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, eTMF etc.
- Supports the Clinical Operation team with the preparation, coordination, and management of regulatory agency inspections.
- Reviews and updates Orchard SOPs, identifying the need for new SOPs, and developing new Quality SOPs as needed.
- Develop and measure GCP quality metrics to drive consistent quality standards throughout the organization.
- Maintain relevant knowledge of appropriate GCP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable.
- Might act as Clinical Development Quality Lead of a specific project or as back-up if required.
- All other duties as assigned.
Education / Key Competencies
- At least ten (10) years of clinical quality assurance experience of which at least five (5) years clinical auditing/oversight experience in the regulatory compliance environment or an equivalent combination of education and experience.
- 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.
- Proficient expertise and knowledge of ICH GCP, FDA, and applicable CFRs guidance documents, systems processes and procedures, which includes working in a QA role supporting regulations compliance.
- Must have a thorough understanding of applicable US and international ICH GCP regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits.
- Stays current with changes to current GCP/GLP/GCLP regulations, guidance, safety reporting including FDA, EU, and other regulatory bodies.
- Experience in clinical operations and handling trial essential documents.
- Additional experience conducting PV, GLP and/or GMP audits is a plus.
Skills & Abilities
- Excellent interpersonal communication, negotiation skills, verbal, written, and presentation skills, maintains high ethical standards, and enjoy working with people and information, making decisions, problem-solving, making the difference.
- Excellent organizational skills and ability to work on multiple projects with competitive timelines is required. Proven ability to manage complex projects.
- Must be capable and willing to travel (10%), including the potential for international travel.
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project)
- Strong attention to detail and respect for the need of accuracy of information.
- Demonstrated ability to work effectively in cross-functional team environment.
- Excellent problem-solving and decision-making skills.