CQV Lead, CCRM Nordic

CQV Lead, CCRM Nordic Are you looking for an exciting opportunity to contribute to the development of next-generation cell and gene therapies and support Sweden's ambition to become a leader in Advanced Therapy Medicinal Products (ATMPs)? Consider applying for the CQV Lead role at CCRM Nordic. About CCRM Nordic CCRM Nordic is a national infrastructure for the commercialization of advanced therapy medicinal products (ATMPs). We are a not-for-profit company located in GoCo Health Innovation City, Mölndal, aiming to build process development and GMP ATMP manufacturing capabilities in the coming years. Our vision is to benefit patients by enabling the commercialization of advanced therapies. Role Summary CQV Lead Location: GoCo Health Innovation City, Mölndal Department: Quality About the Role As CQV Lead, you will lead the efforts in Commissioning, Qualification and Validation of equipment and facilities, as part of the Quality Assurance (QA) team focusing on maintaining compliance with Good Manufacturing Practices (GMP) regulations for ATMPs, relevant quality standards for process development, and company objectives. As CQV Lead, you are expected to create a strategy for CQV, lead the development and execution of validation and qualification processes; defining User Requirement Specifications (URS), performing risk analysis, creating validation plans and test protocols, executing test plans, and evaluating and reporting test and validation outcomes and coverage, in collaboration with the QA manager. Key Responsibilities General · Create CQV strategy, lead the development and execution of validation and qualification processes; define User Requirement Specifications (URS), perform risk analysis, create validation plans and test protocols, execute test plans, evaluate and report test and validation outcomes and coverage, in collaboration with the QA manager. · Collaborate with and support cross-functional teams to address quality-related issues and provide guidance as applicable. Commissioning, Qualification and Validation (CQV): · Develop and implement validation strategies, procedures, and documents aligned with regulatory standards within the field, including GMP for ATMPs, ISO 9001, and applicable standards regulating computerized systems (e.g., GAMP 5). · Stay current with evolving industry regulations and standards, ensuring documentation and practices remain compliant. · Develop and execute commissioning, verification, and qualification test protocols. · Lead, plan, and coordinate testing activities; document results in accordance with internal protocols. · Review technical specifications, engineering drawings, and vendor design submissions for accuracy and compliance. · Analyze test outcomes and prepare comprehensive qualification and validation reports. Quality Assurance: · Design and implement quality procedures and instructions/SOPs, particularly those related to equipment and computerized system qualification and process validation. · Support the development and review of User Requirement Specifications (URSs). · Deliver training across departments as required to promote understanding and adherence to qualification and validation requirements. · Perform risk assessments and develop mitigation strategies to address quality-related issues and deviations. · Conduct and review supplier qualification activities to ensure vendor compliance with quality standards. · Identify and report punch items and deviations; support resolution of technical issues and escalate unresolved concerns. General: · Ensure adherence to all company policies and procedures. · Conduct tasks within the area of responsibility under management oversight, maintaining a compliance mindset. · Perform additional duties as assigned by management, which may include leading projects with a limited scope or collaborating on broader projects. Education & Experience · An academic background (M.Sc./B.Sc.) within a relevant area, advanced degree preferred. · 3-5 years of experience working with qualification and validation within the Life science industry. · Understanding of the V-model (DQ/IQ/OQ/PQ) for process validation and the interpretation of ISO/GMP standards. · Experience in Quality Management Systems/Production/Product/Process Development, preferably within the life science industry. · Experience in a pharmaceutical manufacturing environment, with knowledge of cGMP and facility/equipment/system qualification requirements. · Experience working with technical specifications and external suppliers. · Professional proficiency in English is a must; any Swedish proficiency is a benefit. · Familiarity with regulatory requirements, including EMA, ISO, and ICH guidelines pertaining to biologics and ATMPs. · Ability to work independently and complete assignments within the parameters of given instructions and according to standard operating