Clinical QA Manager

AL2S3 LTD - Durham, NC - AL Solutions are pleased to offer a fantastic opportunity to join a growing Pharma company focused on novel, oral, small-molecule medicines to treat rare diseases. With recent FDA approvals across the globe, this company are looking to increase their headcount and you will be responsible for the development, maintenance and oversight of the GCP activities related to clinical trials they sponsor. As the QA Manager, you will report directly to the Director of Quality Assurance. The Clinical QA Manager will support global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for company. This is a great time to be joining a growing and exciting team! ESSENTIAL DUTIES & RESPONSIBILITIES: Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures. Leads or Manages the oversight of domestic and international investigator site audits, Trial Master Files, Clinical vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH policies and procedures. 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. Provides input and supports observation and CAPA tracking for external Clinical vendors. Participates in the evaluation and qualification of CROs and other clinical vendors/ suppliers in coordination with External Vendor Management. Supports the Clinical Vendor audit management function and the supporting processes, procedures and tracking related activities, including external compliance and audit support of CROs, speciality laboratories and Phase I units. 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 Quality and Clinical management. 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 provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management. Conducts internal audits (systems, processes, vendors, computer system validation) Conducts reviews of clinical and regulatory documents, ensuring quality, accuracy and completeness. May conduct quality assurance review/audit of protocols, Clinical Study Reports, Investigator Brochures, and Integrated Summaries, etc. Assists with the preparation, coordination, and management of regulatory agency inspections. Reviews and update 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 All other duties as assigned. EXPERIENCE BS degree required, preferably in a scientific area. Minimum of at least five (5) years of clinical quality assurance experience and a minimum of 3 years clinical auditing/oversight experience in the regulatory compliance environment or an equivalent combination of education and experience. Excellent communication and negotiation skills; maintain 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 (up to 15%), 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 a cross-functional team environment. Good problem-solving and decision-making skills. Apply AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website www.alsolutions.co.uk for a list of more vacancies.... - Permanent - Full-time

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