Job Description
Quality Manager, CMC and devices This is a rare opportunity to take on a highly responsible role in a young exciting clinical-stage company dedicated to transforming the lives of patients in its therapy areas. With its novel and proprietary drug products and current clinical development programs our clientis aiming to provide substantially improved treatments for patients.This role requires a self-confident ambitious leader looking for an opportunity to deliver success and reap the rewards of strong development growth with the potential for career advancement while creating something new and groundbreaking. Overall Purpose: Responsible for performing key quality tasks in respect of products and development / This is a rare clinical projects. Member of the Quality Team overseeing contract manufacturing (drug and device) and distribution operations, supply chain operations and development functions as well as the development and maintenance of the companys quality management system. Job Spec Support the development,implementation and maintenance of a robust and compliant QMS for each phase of the Device, Combination Product and Packaging Lifecycle, in alignment with company goals, development plans and compliant with all relevant regulations. Provide quality oversight, guidance and monitoring of internal CMC functions and third-party vendors, setting appropriate Quality standards to be met. Ensuring appropriate and compliant documentation of all CMC quality activities is maintained, e.g., deviation investigations, CAPA reports, post implementation impact assessments, root cause analyses, risk assessment, change control. Review and monitor CAPAs/deviations/product complaints identified internallyandreview and approve product complaints, deficiencies, deviations, change controls, and lead investigations where required. Represent for product and analytical/manufacturing related investigations, root cause analysis, and CAPA development and CAPA review and approval at the respective contract manufacturers, distributors and/or suppliers. Collaborate with CMC and Device team and contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product and device components to clinical sites. Participate in due diligence activities associated with strategic partnerships, supporting technology transfer, process scale-up and process improvement projects as needed. Play a lead role in supplier /vendor qualification including conduct or oversight of required audit activities. Manage and/or conduct GxP internal audits. Provide quality related input to equipment and process qualifications, including review/approval of validation plans, protocols and reports. Review approval and oversight of vendor Quality Technical Agreements and manufacturing documentation such as master batch records, labels and artwork requiring quality approval. Evaluate proposed changes to the manufacturing and supply chain processes, including conducting quality impact assessments, and authorize these changes, if appropriate. Provide quality related input into GxP supplier/vendor oversight activities and build authentic relationships withcritical suppliers and contract manufacturers Represent QA within project teams (internal and with vendors) providing input, strategies, options and process improvements. Participate in, review and approve if applicable quality risk assessments for products and processes. With Regulatory Team provide interpretation and application of current and any upcoming regulation/guidance in the industry. Participate in and lead, if necessary, regulatory inspections of and at contract manufacturers, design houses, packagers and laboratories, as required including preparation, hosting and management of CAPA plans where required. Promote quality and compliance mindset at all levels within the organisation. Person Spec University Degree (e.g., graduate biochemist, biologist, pharmacist, chemist, engineer), preferably with Masters level qualification. Minimum 5 years experience in a quality role in a pharmaceutical and/or biotech companypreferably covering areas of CMC and device development and manufacture for clinical supply, QA or QC. Extensive knowledge of QA systems in cGMP environmentswith experience leading GMP audits, including drug product manufacturing and analytical testing sites. Experience on quality documentation for inhalation combination products is beneficial but not essential. Working knowledge and application of device and combination product regulations, including 21 CFR MDR, ISO 13485, ISO 14971, and ICH Q9. Strong interpersonal skills and professional skills to interact readily and easily with key internal and external contacts and within cross functional teams. Comfortable working on their own initiative and able to perform multiple tasks simultaneously and prioritise workload. Flexible, able to adjust, embrace change and a strong fit with the team and willing to roll their sleeves up. Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Have taken this from CSO and minimally adapted. Also works here I think Skills: qUALITY ASSURANCE CMC DRUG DEVELOPMENT 21 CFR 820 ISO 13485 drug devices inhalation Benefits: Work From Home base equity pension healthcare