Quality Regulatory Compliance Lead Citywest

Job description

Quality Regulatory Compliance Lead Full-time, Permanent CityWest The Role The Quality Regulatory Compliance Lead holds overall responsibility for the development, implementation, and ongoing maintenance of the Quality Management System (QMS) and regulatory compliance framework within the pharmaceutical distribution business. This role ensures that the QMS aligns with current GDP, GxP, licence, and regulatory requirements, while upholding best-in-class quality standards. Working collaboratively with both internal and external stakeholders, the Quality Regulatory Compliance Lead will ensure the QMS supports efficient and effective processes across key activities, including wholesale distribution and associated regulatory obligations. The role involves proactively identifying and resolving quality and regulatory compliance issues, escalating matters to senior management when necessary. The individual will serve as Deputy Responsible Person (DRP) on the relevant Wholesale Distribution Authorisation (WDA) licence and support ongoing compliance with licence obligations. This position reports directly to the Regulatory and Compliance QA Manager. Main Responsibilities: • As Quality Compliance Lead you will be responsible for the compliance management of the SCS quality management system. • Serve as the designated Deputy Responsible Person, supporting full compliance with WDA licence requirements and all related GDP, GxP, and applicable regulatory activities within the pharmaceutical distribution business. • Ensure all tasks are executed in alignment with Uniphar Group’s policies and procedures. • Lead and coordinate regulatory, client, and licence-related inspections as necessary. • Manage the Quality and Compliance team and provide mentoring and coaching as required. • Train and support staff in new quality and regulatory compliance initiatives, promoting understanding and consistent implementation across the site. • Maintain and update regulatory standards and procedures in line with applicable regulations, guidelines, licence conditions, and specifications. • Identify opportunities for system improvements or technical issues, collaborating with technical teams to develop and implement effective solutions. • Oversee outsourced activities for the business, ensuring robust compliance processes are in place and responsibilities are clearly defined within the QMS. • Analyse audit results and make recommendation to management on areas that may require additional staff training, improved documentation, or process improvement to remain compliant with regulatory standards. • Collaborate with the wider Quality and Management Teams to identify and implement process improvements. • Contribute to the development of high-quality systems that meet documented specifications, compliance standards, licence requirements, and business objectives. • Lead cross-functional meetings to triage and resolve quality and regulatory compliance issues. • Foster strong relationships with internal and external stakeholders, promoting a culture of continuous improvement. • Design, prepare, distribute and maintain weekly & monthly reports/KPIs summarising information regarding Quality within the warehouse environment in conjunction with the Head of Quality for SCR • Engage in ongoing professional development and support team learning to stay current with evolving regulations and ensure timely implementation. • Undertake additional projects or activities as assigned by the Head of SC Quality, Group Quality Director/RP and/or other Senior Managers. QUALIFICATION, EXPERIENCE & SKILLS REQUIRED • 3–5 years of professional experience in a regulated pharmaceutical distribution environment, including GDP and GxP activities. • Experience supporting compliance with Wholesale Distribution Authorisation (WDA) licence requirements. • Demonstrated experience in regulatory compliance activities relevant to pharmaceutical distribution. • Proven track record of participation in regulatory authority inspections. • Strong leadership capabilities with the ability to manage and develop a small team effectively. • Excellent interpersonal and communication skills, with the ability to engage confidently across all levels of the organisation. • Highly developed organisational, analytical, problem-solving, influencing, and management skills. • Project management experience is advantageous. • Proficient in standard software applications, including word processing, spreadsheets, and data analysis tools. • Ability to thrive in a fast-paced, collaborative environment with sound decision-making and problem-solving abilities. • Strong time management and prioritisation skills, with a focus on meeting tight and overlapping deadlines. • Exceptional attention to detail, organisational skills, and accuracy in record-keeping. • Capable of working independently with minimal supervision. • Familiarity with validation methodologies. • Commercial awareness and business acumen. • A bachelor’s degree in a science or healthcare is preferred.