Responsible for providing senior support in planning, organizing and/or evaluating the day-to-day delivery of global quality assurance (QA) services for Alimentiv Holdings companies. Responsible for supporting the businesses in quality assurance, policy planning and development, ongoing quality improvement through clinical and/or laboratory audit and liaison with other business units and external partners. Will also provide support, expertise, and industry best practice guidance.
Quality Assurance Implementation
- Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
- Collaborating with management/functional experts or Sponsors to identify requirements of the organization in order to conduct internal audits, site audits, vendor assessments and vendor audits.
- Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
- Develop QA processes, train and oversee junior QA staff.
- Liaise with the Human Resources department and/or other stakeholders to ensure that all staff are qualified.
- Remain current on and ensure internal awareness of regulatory trial and/or laboratory conduct standards, requirements, and accreditations (e.g., CAP/CLIA) including local requirements as applicable.
- Identify changes to standards and regulations governing Clinical Laboratories and/or Clinical Research and provide recommendations for implementation as required.
Regulatory, Ethical, and Audit Monitoring
- Remain current on, interpret and communicate changes to regulatory trial and/or laboratory conduct standards and requirements.
- Identify, implement and/or develop policies, processes, and/or training to meet these standards.
- Plan/lead/facilitate Sponsor and regulatory inspections, certifications and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.
- Perform internal audits and vendor audits, ensuring that all observations are appropriately addressed and resolved.
- Communicate audit findings to internal stakeholders and provide guidance to teams regarding the development of Root Cause Analysis and Corrective Preventive Actions.
- Liaise with other departments in the completion of Sponsor requests for information.
- Support internal departments with privacy related questions or inquiries.
Product/Service Consulting
- Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains.
Qualifications
- The successful candidate will possess either an undergraduate or Master's degree with a minimum of 4-6 years of related experience.
- Life Sciences, Clinical Research, Information Technology, Laboratory Science or Clinical Quality Assurance specialty preferred.
- Demonstrated knowledge and experience in Clinical Quality and/or a Clinical (Pathology) Laboratory preferred
- Strong analytical, critical thinking and problem-solving skills.
- Knowledge of ICH GCP and GLCP global regulations governing Clinical Research and or laboratory research and global privacy regulations.
- Proficient in the use of Quality Management Systems.
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