Quality Assurance tjänst till Ledande bolag i Göteborg!

About CCRM Nordic CCRM Nordic breaks down the bottlenecks that slow life-changing therapies from lab to patient. Based at GoCo Health and Innovation City in Mölndal, we provide ATMP teams across Sweden, the Nordics and Europe with the infrastructure, know-how and partner network they need, whether that means a single consultation or a long-term manufacturing collaboration. We have invested in a brand-new GMP manufacturing facility with five processing rooms on floor 16 of GoCo House. We are now building the founding team that will shape how this facility runs, and are looking for a Manufacturing Team Lead ready to be part of something genuinely exciting. The opportunity This is a founding role. As one of the first hires into the manufacturing team, you will help build the structure, not just step into it. From authoring SOPs and batch records to training operators and leading quality investigations, this role sits at the operational heart of CCRM Nordic's manufacturing capability. You will lead a team of up to six GMP operators across multiple processing rooms, manage day-to-day scheduling and training, and act as the department's SME for quality systems. You will work alongside PD and MSAT colleagues on new product introductions and technology transfers, and collaborate with our Validation team on equipment qualification and process establishment. Key responsibilities Manufacturing Operations Lead day-to-day GMP manufacturing operations across multiple processing rooms, ensuring clinical materials are delivered on time and to the highest quality standard. Perform and oversee hands-on processing including cell culture, bioreactor operation, Tangential Flow Filtration (TFF) and chromatography. Schedule and manage housekeeping, environmental monitoring and cleaning activities, internally and with external contractors. Maintain full inventory control, ensuring consumables and raw materials are stocked and within expiry. People & Team Leadership Line manage a team of up to six pharmaceutical operators, including performance management, workload planning and day-to-day support. Design and deliver training plans to ensure every team member is qualified for all processing and ancillary activities. Act as a role model for a collaborative, high-performance culture: mentoring and developing the people around you. Quality & Compliance Serve as the manufacturing SME for all GMP quality matters, leading incident investigations, root cause analyses, change controls and CAPAs. Ensure all operations are executed in strict accordance with approved SOPs, Batch Manufacturing Records and current GMP guidelines. Author and review SOPs, batch records, logbooks, COSHH assessments and User Requirement Specifications for new equipment. Support regulatory inspections and ensure the facility is always inspection-ready. Collaborate with the Validation Department on equipment calibration, qualification and shutdown planning. New Product Introduction & Tech Transfer Partner with PD and MSAT teams to introduce new products and processes into the GMP suite. Support technology transfers into and out of the facility, including handovers to clients or CMOs. What we are looking for Essential Minimum 5 years' GMP manufacturing experience, with a strong focus on bioproduction or ATMPs. Proven track record as a line manager of a GMP manufacturing team. Hands-on experience with ATMPs, ideally including Viral Vectors or similar advanced modalities. Degree in bioprocessing, microbiology or a related life science discipline, or equivalent experience. Deep working knowledge of GMP QMS systems: quality incidents, change controls and CAPA management. Experience authoring SOPs, batch records and validation documentation. Strong communication skills and ability to collaborate across functions. Highly Desirable Experience in Tech Transfer and process validation. Hands-on operation of TFF systems, including Repligen platforms. Experience supporting or participating in regulatory inspections. The person We are looking for someone who is: A strong team player who invests in the people around them and understands that great manufacturing is a collective achievement. Adaptable and calm under pressure, able to pivot when processes change, timelines shift or unexpected challenges arise. Energised, not overwhelmed, by the complexity of a new facility and evolving product portfolio. Service-oriented and delivery-focused, with high personal standards for accuracy and thoroughness. An excellent organiser who can hold multiple priorities without letting quality slip. Why join CCRM Nordic? CCRM Nordic is an innovation-led organisation at the frontier of ATMP development. Joining now means helping to shape the team, culture and operational standards of a facility that will directly contribute to getting advanced therapies to patients faster. A rare opportunity to join a founding manufacturing team and leave your mark on how things are built. Work alongside world-class scientists and process development experts on cutting-edge ATMP programmes. A collaborative, supportive environment where your expertise is genuinely valued. Clear pathways for growth as the team expands from Phase 1 through to full multi-project manufacturing capacity. Competitive salary in line with the Swedish pharmaceutical market. Ready to build something important? We'd love to hear from you.

Professional Galaxy is an IT and technology consulting company that provides highly specialized expertise within IT, software development, SAP, purchasing, electronics and mechanical design. We collaborate with experienced senior experts and deliver strategic value-creating expertise to some of Sweden's most complex and analytically demanding projects. Our focus is always on high quality, professionalism and clear, measurable results. We are now seeking a Supply Chain Manager for Clinical Trial medications for one of our clients. About the assignment: Would you like to utilize your planning and supply chain knowledge to lead clinical supplies for your portfolio of global clinical studies? With constant new products and launches, there has never been a better time to join Global Clinical Supply Chain and shape our future with a significant contribution to life-changing medicines. We have an exciting opportunity for talented Supply Chain Managers to join our Clinical Study Supply Chain team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams, and we make sure clinical trial medications are available at the right quality, in the right quantity at the right time for every patient taking part in xx trials all over the world. Our goal is to never miss a patient. In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Tasks and responsibilities/The role: In this role you will project manage the design, plan, and set-up of the study supply chain to ensure on time delivery of clinical supplies. You will also lead a cross-functional team enabling continuous dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study. To be successful in this role you need to be a fast learner, self-driven and comfortable working in a high pace R&D environment. You need to be a collaborative team player, flexible and have strong communication, planning and problem-solving skills. Your main responsibilities will include: • Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. • Ensure effective communication with project teams and key partners across a global network. • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies. • Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction. • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning. • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls. Soft skills: • Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries • Ability to adapt and operate in bespoke multiple systems. Desirable for the role: • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice) • Knowledge of clinical development processes relevant to the supply of clinical materials • Lean knowledge and understanding • Experienced in handling Quality Events (Deviations, Change Controls, Complaints Location: Göteborg Start date: 2026-06-01 End date: 2027-05-31 Application Deadline: 2026-04-19 Are you the right person for the assignment, or do you want to recommend a strong candidate? Do not hesitate to contact us. Please apply directly through our system with: - Your updated CV in english - Availability to start the assignment In the motivation, describe why you are suitable for this assignment - refer to previous consulting assignments, employmxent, education and personal qualities. Please note: We do not accept any applications through mail. All applications have to be sent through the portal to be valid. Offer continuously: Please note that for this role we offer continuously. That means that we sometimes remove the assignments before the deadline. If you are interested, we recommend that you apply immediately.