Role Summary
Quality Control Manager
Location: GoCo Health Innovation City, Mölndal
Department: Quality
About the role
As Quality Control Manager, you will lead the establishment and management of the GMP QC laboratory and environmental monitoring program for ATMP manufacturing. This strategic and hands-on role is key to ensuring regulatory compliance, robust analytical capabilities, and operational excellence in a dynamic environment.
Key responsibilities
Establishment of QC Infrastructure
- Support the establishment and successful operation of CCRM Nordic GMP QC laboratory.
- Develop, implement, and maintain QC-related SOPs, workflows, and procedures aligned with CCRM Nordic’s QMS, including analytical testing, EM, and Contamination Control Strategy (CCS).
- Establish and implement the Environmental Monitoring (EM) control program, procedures and trending including GMP cleanroom qualification and classification in collaboration with QA and Manufacturing team.
- Lead the analytical method implementation lifecycle, including transfer, qualification, and validation for IPC and release testing.
- Ensure QC activities comply with GMP for ATMPs, EMA, Ph. Eur., ISO9001 and ICH guidelines as required.
- Lead and support investigations of deviations, OOS, CAPA, and change controls related to QC.
- Prepare for and represent QC during internal, client, and regulatory audits and inspections.
- Collaborate with MSAT and PD teams to ensure robust analytical support for process development and manufacturing.
- Drive initiatives to optimize QC workflows, reduce turnaround times, and enhance compliance.
Operational Leadership
- Build, train, and manage the QC team, ensuring competence in analytical methods and QC processes relevant to ATMPs (e.g., cell-based assays, molecular biology, microbiology).
- Oversee daily QC operations including in-process control (IPC), release testing, material control, environmental monitoring, and stability studies.
- Partner with Manufacturing, QA, MSAT, and PD to ensure seamless product release and continuous improvement.
Education & Experience
- Master’s degree or PhD in Biology, Biotechnology, Biochemistry, or a related scientific field.
- Minimum 7 years of experience in Quality Control or analytical development within GMP-regulated biopharma, with at least 3 years in a leadership or managerial role.
- Proven experience in establishing, transferring, qualifying, and validating analytical methods, preferably in cell and gene therapy or ATMPs.
- Strong knowledge of ATMPs, GMP, EMA/FDA regulations, ISO9001, Ph. Eur., and ICH guidelines.
- Hands-on expertise in microbiological testing, molecular biology techniques, and cell-based assays.
- Experience in cleanroom behaviour and cleanroom Environmental Monitoring.
- Experience with viral vector testing (e.g., AAV, lentivirus) is a strong asset.
- Familiarity with Contamination Control Strategy (CCS) and Annex 1 is highly desirable.
- Experience with digital QC systems such as LIMS, eEMS, and eQMS is an advantage.
- Demonstrated ability to lead teams, manage projects, and interact effectively with regulatory authorities and clients.
- Excellent organizational, documentation, and communication skills.
- Fluent in English (CCRM Nordic’s business language).
- Proficiency in document management software such as Microsoft Office.
Personal Attributes
- Structured and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
- Strong leadership and team-building skills, with a collaborative mindset and ability to work cross-functionally.
- Quality-driven, proactive, and solution-oriented with a continuous improvement mindset.
- Excellent communication skills, both written and verbal.
- Comfortable working in a dynamic start-up environment with evolving processes and responsibilities.
- Deep understanding of regulatory frameworks and GMP principles, particularly those governing ATMPs.
