CQV Lead, CCRM Nordic

Looking for an exciting opportunity to contribute to the development of next-generation cell and gene therapies and to Sweden's ambition of becoming 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 based in GoCo Health Innovation City, Mölndal, that aims to build process development and GMP ATMP manufacturing capabilities during 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 strategy for CQV, lead the development and execution of processes related to validation and qualification; defining User Requirement Specifications (URS), performing risk analysis, creating validation plans and test protocols, executing test plans, evaluating and reporting test and validation outcome and coverage, in collaboration with the QA manager.

Key responsibilities

General

• Creating strategy for CQV, lead the development and execution of processes related to validation and qualification; defining User Requirement Specifications (URS), performing risk analysis, creating validation plans and test protocols, executing test plans, evaluating and reporting test and validation outcome 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, including 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.
• Analyse 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 e.g. may lead projects with a limited scope or collaborate on broader projects as applicable.

Education & Experience

• An academic background (M.Sc./B.Sc.) within 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 to carry out assignments to completion within parameters of instructions given and according to standard operating procedures (SOPs)
• Strong attention to detail and analytical skills, with the ability to collaborate effectively with cross-functional teams and communicate quality-related issues clearly and concisely.
• Demonstrated ability to interact effectively with cross-functional teams.

How to Apply

Send your CV and a brief cover letter outlining your relevant experience to Applications reviewed on a rolling basis.