Quality Assurance Manager

As an experienced Clinical Quality Assurance Manager within cancer research, your role at Sarah Cannon Research Institute (SCRI) UK will involve supporting the delivery of high-quality clinical trials. You will ensure best practices by developing and shaping the QA framework, enhancing SOPs, and ensuring alignment with regulatory requirements and industry standards. Your responsibilities will also include supporting process improvement initiatives, ensuring site processes comply with approved study protocols and regulatory framework, providing guidance and training to the research team, leading routine audits internally and externally, and supporting sponsor and regulatory inspections. Key Responsibilities: - Develop and shape the QA framework and enhance SOPs - Ensure alignment with regulatory requirements and industry standards - Support process improvement initiatives - Ensure site processes comply with approved study protocols and regulatory framework - Provide guidance, training, and support to the research team - Lead routine audits internally and externally - Support sponsor and regulatory inspections Qualifications Required: - Bachelors or Masters degree in nursing, pharmacy, or other science-related field - Solid understanding of GCP & MHRA Regulations, GMP, Good Documentation Practices (GDP), and/or Pharmacovigilance (PV) knowledge - Sound Knowledge of the UK Clinical Trials Regulations, EU Directive (2001/20/EC), ICHGCP R2, and other guidelines relevant to clinical trials of investigational medicinal products - Experience leading internal and/or external audits in line with Good Clinical Practice (GCP) regulations and standards As part of HCA UK, you will have the opportunity to work with one of the world's leading healthcare providers. With over 50 years of experience, HCA UK is dedicated to providing exceptional care for both patients and employees. You will have access to unrivalled opportunities for career progression, internal and external courses, and working conditions that prioritize mental and physical wellbeing. HCA UK offers a range of flexible benefits for employees, including: - 25 days holiday each year (plus bank holidays) increasing with service, with the option to buy or sell leave - Private Healthcare Insurance for treatment at leading hospitals - Private pension contribution increasing with length of service - Season Ticket Loan and Cycle to Work scheme - Group Life Assurance from day one - Critical illness cover - Corporate staff discount for all facilities, including Maternity packages at The Portland - Comprehensive range of flexible health, protection, and lifestyle benefits At HCA UK, exceptional care starts with people. The organization celebrates unique perspectives, different experiences, kindness, compassion, honesty, integrity, fairness, loyalty, respect, and dignity. The core values of HCA UK reflect a commitment to the care and improvement of human life for both patients and colleagues. HCA UK is committed to creating an inclusive workplace where everyone feels comfortable bringing their full selves to work. As a Disability Confident committed organization, flexible working arrangements and reasonable adjustments are offered throughout the recruitment process and in the workplace to accommodate individual needs.,