quality control manager, ccrm nordic.

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 GMP Manufacturing QC related tasks, analytical methods and QC processes relevant to ATMPs (e.g., EM, cell-based assays, molecular biology, microbiology).

• Oversee daily QC operations including, material control, in-process control (IPC), release testing, environmental monitoring and stability studies.

• Partner with QA, GMP Manufacturing, MSAT, and CMC PD/AD to ensure seamless product release and continuous improvement.

Join a pioneering team advancing next-generation therapies in a collaborative environment with opportunities for growth and real impact on transformative medicines.

Requirements for the role:

• Master’s degree or PhD in Biology, Biotechnology, Biochemistry, Pharmacy or a related scientific field.

• Minimum 7 years of experience in Quality Control or analytical development within GMP-regulated biopharma.

• Experience in cleanroom behaviour and cleanroom Environmental Monitoring.

• Proven experience in establishing, transferring, qualifying, and validating analytical methods.

• Fluent in English (CCRM Nordic’s business language).

• Proficiency in document management software such as Microsoft Office.

Desirable experience:

• Experience in a leadership or managerial role.

• Knowledge of cell and gene therapy or ATMPs.

• Hands-on expertise in microbiological testing, molecular biology techniques, and cell-based assays.

• Experience with viral vector testing (e.g., AAV, lentivirus) is a strong asset.

• Strong knowledge of ATMPs, GMP, EMA/FDA regulations, ISO9001, Ph. Eur., and ICH guidelines.

• 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.

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.