Specialist Compliance Excellence (m/f/d) in Entlebuch

ph3bSpecialist Compliance Excellence (m/f/d) /b /h3 pWerthenstein BioPharma GmbH Vacant since : Number of jobs : 1 6105 Schachen LU (LU) 100% Immediately Permanent Registration requirement /p pOur Schachen serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them. /p pOur Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement. /p pThe Compliance Excellence Specialist (P2) supports operational compliance and quality system activities for GMP biologics manufacturing at our Schachen. This role contributes to right-first-time execution, operational continuity, and inspection readiness by supporting investigations, documentation, change controls, risk records, and continuous improvement activities within assigned areas. Working with direction and guidance, the role applies developing GMP and quality system knowledge to solve straightforward compliance topics, support timely closure of quality records, and contribute to cross-functional alignment with Manufacturing, Quality, Engineering, and MSAT. The position focuses on reliable execution, learning through hands‑on assignments, and building the experience required to independently manage broader compliance topics over time. /p h3Responsibilities: /h3 h3Compliance Support Issue Resolution /h3 ul liSupport the resolution of GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope. /li liApply standard procedures and GMP expectations to assess issues and propose recommended actions with guidance. /li liSupport root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes. /li liEscalate risks, delays, or unclear situations in a timely and structured manner. /li /ul h3Change Risk Management /h3 ul liSupport GMP product‑related change controls and risk records under guidance. /li liCollect and prepare information needed for risk assessments, change evaluations, and implementation planning. /li liEnsure assigned documentation tasks are completed accurately and on time. /li liContribute to compliant and efficient execution of changes within area of responsibility. /li /ul h3Operational Support /h3 ul liProvide compliance support for production‑related questions, documentation topics, and issue follow‑up. /li liSupport Manufacturing teams in resolving standard and non‑standard requests with assistance as needed. /li liCollaborate with colleagues inside and outside the department to gather input and align next steps. /li liHelp ensure operational decisions remain aligned with GMP expectations. /li /ul h3Performance Management Continuous Improvement /h3 ul liSupport monitoring and tracking of quality, compliance, and operational performance indicators. /li liContribute to data collection, trend review, and preparation of performance updates. /li liIdentify improvement opportunities within assigned tasks or processes and propose practical solutions. /li liParticipate in operational excellence activities such as Gemba, 5S, and process improvement routines. /li /ul h3Inspection Readiness Quality Systems /h3 ul liSupport inspection readiness by helping ensure GMP documentation, deviations, investigations, and changes are complete, accurate, and inspection‑ready. /li liParticipate in preparation activities for internal audits, external audits, and regulatory inspections. /li liMaintain assigned records and documentation in line with procedural and compliance requirements. /li liSupport subject matter experts during audits or inspections when required. /li /ul h3Project Support Collaboration /h3 ul liContribute to small projects, subteams, or workstreams with guidance. /li liDeliver assigned project tasks according to agreed timelines and communicated expectations. /li liBuild effective working relationships with Manufacturing, Quality, Engineering, and MSAT. /li liActively learn from experienced colleagues and contribute to team knowledge sharing. /li /ul h3Your Profile: /h3 ul liBachelor’s or Master’s degree in a scientific, engineering, or technical discipline. /li liInitial experience in GMP‑regulated manufacturing, quality systems, technical operations, or a related area. /li liGood understanding of GMP expectations, documentation standards, and quality processes, with willingness to further develop expertise. /li liAbility to analyze issues using standard procedures and propose solutions with guidance. /li liStrong collaboration skills and ability to work with colleagues across Manufacturing, Quality, Engineering, and MSAT. /li liStrong communication skills in German and English. /li /ul pOur Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence». /p pWe are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us. /p pOur Werthenstein BioPharma site in Schachen is where we conduct cutting‑edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients. /p h3Additional Information: /h3 pRelocation: None Visa Sponsorship: None Travel Requirements: 10% Flexible Working Arrangements: onsite Shift: No Valid Driver License: No Hazardous Materials: No /p h3Work location /h3 ul libWork location /b 6105 Schachen LU (LU) /li /ul h3Workload /h3 ul libWorkload /b 100% /li /ul h3Employment start /h3 ul libEmployment start /b Immediately /li /ul h3Employment duration /h3 ul libEmployment duration /b Permanent /li /ul h3Qualification /h3 ul libQualification /b skilled /li /ul h3Work experience /h3 ul libWork experience /b More than 3 years /li /ul h3Education /h3 ul libEducation /b Bachelor’s degree from a university or equivalent /li /ul h3English /h3 ul libEnglish /b Orally : Very good knowledge Written : Very good knowledge /li /ul h3German /h3 ul libGerman /b Orally : Very good knowledge Written : Very good knowledge /li /ul h3By email /h3 ul libBy email /b /li /ul /p #J-18808-Ljbffr