Specialist Compliance Excellence (m/f/d)

Werthenstein BioPharma GmbH; Schachen; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Werthenstein BioPharma GmbH in Schachen, Lucerne, is seeking a Specialist Compliance Excellence to support GMP compliance and quality systems for biologics manufacturing. The role focuses on deviation investigations, change controls, risk management, and continuous improvement, with collaboration across Manufacturing, Quality, Engineering, and MSAT.

The ideal candidate holds a Bachelor’s or Master’s degree in a scientific field, has GMP exposure, and strong German and English communication

Qualifikationen

• Bachelor’s degree in a scientific discipline; Master’s preferred.
• Initial experience in GMP-regulated manufacturing or quality systems.
• Strong GMP documentation understanding and quality processes.
• Ability to analyze issues and propose solutions with guidance.
• Excellent collaboration across Manufacturing, Quality, Engineering, and MSAT.
• Strong German and English communication skills.

Aufgaben

• Support GMP deviation records, investigations, and CAPAs within scope.
• Assist with change controls, risk records, and risk assessments.
• Provide compliance support for production-related questions and documentation.
• Collaborate with cross-functional teams to align next steps.
• Help ensure inspection readiness and support audits and inspections.
• Monitor quality and performance indicators and contribute to improvements.

Kenntnisse

GMP knowledge

Quality systems experience

German language

English language

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s degree in a scientific/engineering discipline

Jobbeschreibung

Specialist Compliance Excellence (m/f/d)

Werthenstein BioPharma GmbH Vacant since : 03.09.2026 Number of jobs : 1 6105 Schachen LU (LU) 100% Immediately Permanent Registration requirement

Our 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.

Our 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.

The 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.

Responsibilities:

Compliance Support & Issue Resolution

• Support the resolution of GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope.
• Apply standard procedures and GMP expectations to assess issues and propose recommended actions with guidance.
• Support root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes.
• Escalate risks, delays, or unclear situations in a timely and structured manner.

Change & Risk Management

• Support GMP product‑related change controls and risk records under guidance.
• Collect and prepare information needed for risk assessments, change evaluations, and implementation planning.
• Ensure assigned documentation tasks are completed accurately and on time.
• Contribute to compliant and efficient execution of changes within area of responsibility.

Operational Support

• Provide compliance support for production‑related questions, documentation topics, and issue follow‑up.
• Support Manufacturing teams in resolving standard and non‑standard requests with assistance as needed.
• Collaborate with colleagues inside and outside the department to gather input and align next steps.
• Help ensure operational decisions remain aligned with GMP expectations.

Performance Management & Continuous Improvement

• Support monitoring and tracking of quality, compliance, and operational performance indicators.
• Contribute to data collection, trend review, and preparation of performance updates.
• Identify improvement opportunities within assigned tasks or processes and propose practical solutions.
• Participate in operational excellence activities such as Gemba, 5S, and process improvement routines.

Inspection Readiness & Quality Systems

• Support inspection readiness by helping ensure GMP documentation, deviations, investigations, and changes are complete, accurate, and inspection‑ready.
• Participate in preparation activities for internal audits, external audits, and regulatory inspections.
• Maintain assigned records and documentation in line with procedural and compliance requirements.
• Support subject matter experts during audits or inspections when required.

Project Support & Collaboration

• Contribute to small projects, subteams, or workstreams with guidance.
• Deliver assigned project tasks according to agreed timelines and communicated expectations.
• Build effective working relationships with Manufacturing, Quality, Engineering, and MSAT.
• Actively learn from experienced colleagues and contribute to team knowledge sharing.

Your Profile:

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Initial experience in GMP‑regulated manufacturing, quality systems, technical operations, or a related area.
• Good understanding of GMP expectations, documentation standards, and quality processes, with willingness to further develop expertise.
• Ability to analyze issues using standard procedures and propose solutions with guidance.
• Strong collaboration skills and ability to work with colleagues across Manufacturing, Quality, Engineering, and MSAT.
• Strong communication skills in German and English.

Our 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».

We 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.

Our 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.

Additional Information:

Relocation: None Visa Sponsorship: None Travel Requirements: 10% Flexible Working Arrangements: onsite Shift: No Valid Driver License: No Hazardous Materials: No

Work location

• Work location 6105 Schachen LU (LU)

Workload

• Workload 100%

Employment start

• Employment start Immediately

Employment duration

• Employment duration Permanent

Qualification

• Qualification skilled

Work experience

• Work experience More than 3 years

Education

• Education Bachelor’s degree from a university or equivalent

English

• English Orally : Very good knowledge Written : Very good knowledge

German

• German Orally : Very good knowledge Written : Very good knowledge

By email

• By email [e-mail]