Quality Control Manager, Ccrm Nordic
Randstad AB / Organisationsutvecklarjobb / Mölndal
2025-12-04
Visa alla organisationsutvecklarjobb i Mölndal,
Göteborg,
Partille,
Härryda,
Kungsbacka eller i
hela Sverige Visa alla jobb hos Randstad AB i Mölndal,
Göteborg,
Partille,
Härryda,
Kungsbacka eller i
hela Sverige Job description
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 Quality Control Manager role at CCRM Nordic.
Location: GoCo Health Innovation City, Mölndal
Department: Quality
Position Overview: Line management and staff responsibility reporting to Director 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 CDMO environment.
Does this sound like you? Submit your CV as soon as possible. Selection is ongoing - we won't wait until the last day! In this recruitment process, CCRM Nordic AB is collaborating with Randstad AB, where the responsible recruiter is Maria del Carmen Leiva Arrabal, PhD (
maria.leiva@randstad.se), who will be happy to answer your questions.
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 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.
Qualifications
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.
About the company
Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world's most valued working life partner. By combining our passion for people with the power of today's technology, we support people and organizations in realizing their true potential. We call it Human Forward.
Ersättning Monthly
Så ansöker du Sista dag att ansöka är 2026-01-07
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Kontakt Maria del Carmen Leiva Arrabal
maria.leiva@randstad.se +46723946075 Jobbnummer 9629120