The Role

Drive and Support the Site Quality Management System Metrics Support and optimize the development and functioning of Quality Assurance (QA) systems to advance the Quality culture. Proactively communicate compliance requirements to the site and serve as a role model for the necessary conduct to maintain compliance with GCP/GxP practices. Ensure efficient and effective implementation of regulatory requirements into the quality management system. Support Quotient Sciences Quality Assurance function during support of regulatory Inspections as applicable. Support the conduct of internal audits for the site. Plan and execute GDP trainings for the site as needed To comply & adhere to GCP/GxP guidelines and regulations as required of this role.

Main Tasks and Responsibilities

Provide a strong strategic and practical management of the GCP aspects of Quotient’s quality related activities to ensure continued compliance with required regulatory standards Involvement with the management of Regulatory Inspections. Key contact in the preparation, conduct and follow up of GCP Regulatory Inspections. Assistance with planning, conduct, reporting and follow up of GCP audits (internal and sub-contractor or supplier). Management of the Quality Management System Program through Veeva (Deviations, CAPAs, Chance Control, Document Requests, Document Change Controls, and Audit reports). Provide guidance and feedback during investigations of quality issues. Notify document Owners of documents requiring periodic review approximately 3 months in advance of periodic review due date. Support Key Quality Performance Indicators to drive Operational excellence and problem-solve trends by collection of data and analysis. Serve as a QA resource to provide input and guidance to cross-function teams on quality issues, Conduct peer review of documentation, as necessary. Perform study audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP. Provide guidance on corrective and preventive actions to address audit findings in collaboration with cross-functional team members. Develop, implement, and maintain the site’s quality system.  Author, review and approve SOPs and assure compliance with current regulatory requirements.  Assure documents are issued, controlled, and archived in accordance with company procedures. Collaborate w2ith fucntional area managers during new employee onboarding processes. Support Line Managers with GDP Trainings to ensure appropriate Training Material is Available. Review of governance documents for compliance with Quotient and Regulatory Requirements, and or Quality Event driven changes. Participate in the change control process to ensure changes to processes, systems, equipment, and facilities are appropriately assessed and implemented after proper verification of changes. Interpret and provide guidance, coaching, and mentoring to other functions and, where necessary customers on regulatory requirements and expectations. Participate in the planning and execution of customer audits related to clinical projects.  Assure that root cause(s) are identified, and effective corrective actions are implemented in a timely manner to mitigate the recurrence of issues.  Review Continuous Improvement Proposals (and associated action items) to assess whether the initiative constitutes a change that impacts the GxP status of facilities, systems, processes, personnel, or equipment. Develop productive, dynamic, professional working relationships founded on trust and respect with project team personnel and customers.  Coach and mentor other QA clinical personnel and assure alignment and consistent decision-making within the team. QMS Management Perform other duties as required.

The Candidate

Bachelor’s Degree in a scientific field B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology. Minimum 5 years of relevant experience in life sciences quality or relevant experience in a regulated field Knowledge of Quality Management Systems, GCP requirements, and ICH Guidelines, ICH Q9, 21 CFR Part 11, Data Integrity, Risk Approach and Quality by Design. Experience of conducting internal audits and hosting client audits for compliance with company procedures and regulatory requirements, hosting customer audits. Excellent written, mentoring, influencing, persuasion and oral communication skills. Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams. Strong interpersonal skills with a special focus on customer satisfaction. Work independently with minimal supervision with the ability to multi-task, work in a fast-paced environment and prioritize work to assure business and compliance objectives are met. Detail oriented with excellent problem-solving and organizational skills.