Quality Manager

EPM Scientific; Muttenz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

EPM Scientific is seeking an experienced Quality Assurance Manager in Switzerland to lead QA oversight across manufacturing, qualification, validation and quality systems within a cGMP-regulated facility.

You will work closely with the Head of QA and Regulatory Affairs, remain hands-on, and drive continuous improvement while ensuring investigations, CAPA and change controls are handled according to applicable standards.

Qualifikationen

• Hands-on QA experience in regulated pharma/manufacturing environments.
• Strong knowledge of cGMP requirements and quality systems.
• Experience with deviations, investigations, CAPA and change controls.
• Knowledge of equipment qualification and process validation.
• German and English professional fluency.

Aufgaben

• Provide QA oversight across manufacturing, qualification, validation, quality systems and continuous improvement activities.
• Review and approve quality documentation including deviations, investigations and change controls.
• Support internal and external audits, supplier quality activities and inspection readiness.
• Collaborate with Production, Quality Control, Engineering and R&D to ensure compliant manufacturing and testing.
• Lead QMS improvements and drive CAPA program to close out within timelines.
• Ensure data integrity and qualification documentation are current and compliant.

Kenntnisse

QA experience

cGMP knowledge

QMS expertise

root cause analysis

CAPA

deviations investigations

change controls

data integrity

audit support

German/English fluency

Ausbildung

Master's or PhD in Chemistry/Engineering/Pharmaceutical Sciences

Tools

CSV (Computer System Validation)

Jobbeschreibung

Location: Switzerland
Industry: Pharmaceutical Manufacturing / API / CDMO

A specialist pharmaceutical manufacturing organisation is looking for an experienced Quality Assurance Manager to join its Quality Assurance and Regulatory Affairs function in Switzerland.

This role offers the opportunity to take broad ownership of pharmaceutical quality systems within a cGMP-regulated manufacturing environment. You will work closely with the Head of Quality Assurance and Regulatory Affairs, providing QA oversight across manufacturing, qualification, validation, quality systems and continuous improvement activities.

This is an individual contributor position with no direct reports, making it well suited to an experienced Quality professional who enjoys remaining hands‑on while influencing quality standards across a manufacturing site.

Key Responsibilities

Location: Switzerland
Industry: Pharmaceutical Manufacturing / API / CDMO

A specialist pharmaceutical manufacturing organisation is looking for an experienced Quality Assurance Manager to join its Quality Assurance and Regulatory Affairs function in Switzerland.

This role offers the opportunity to take broad ownership of pharmaceutical quality systems within a cGMP-regulated manufacturing environment. You will work closely with the Head of Quality Assurance and Regulatory Affairs, providing QA oversight across manufacturing, qualification, validation, quality systems and continuous improvement activities.

This is an individual contributor position with no direct reports, making it well suited to an experienced Quality professional who enjoys remaining hands‑on while influencing quality standards across a manufacturing site.

• Support the development, maintenance and continuous improvement of site‑wide cGMP quality systems, standards and processes.

• Review and approve manufacturing and quality documentation, including Master Batch Records, batch records, deviations, out‑of‑specification investigations and change controls.

• Provide Quality Assurance oversight for equipment, facilities, utilities, process automation and computerised systems.

• Ensure qualification and validation documentation remains current, compliant and fit for purpose.

• Support Computer System Validation, data integrity, equipment change control and quality risk management activities.

• Review and approve SOPs, investigations, risk assessments, changes and other Quality Management System documentation.

• Ensure quality incidents are thoroughly investigated and that corrective and preventive actions are implemented within agreed timelines.

• Support internal and external audits, supplier quality activities and inspection‑readiness programmes.

• Partner with Production, Quality Control, Engineering, R&D and other internal stakeholders to ensure products are manufactured and tested in accordance with applicable quality standards.

• Identify opportunities to simplify processes, improve quality performance and strengthen the overall compliance culture across the site.
  

Candidate Profile

The organisation is interested in speaking with experienced Quality Assurance professionals who can demonstrate:

• A strong background within pharmaceutical, API, chemical manufacturing, CDMO or another closely regulated production environment.

• Several years of hands‑on Quality Assurance experience, ideally supported by broader exposure to Quality Control, R&D, Engineering or Production.

• Advanced knowledge of cGMP requirements, pharmaceutical regulations and Quality Management Systems.

• Experience managing deviations, investigations, root cause analysis, CAPA, change controls and quality risk assessments.

• Knowledge of equipment qualification, process validation or Computer System Validation.

• Experience supporting quality audits, regulatory inspections or supplier quality activities.

• The ability to work independently and provide credible Quality guidance to technical and operational stakeholders.

• A Master's degree or PhD in Organic Chemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or a related scientific discipline.

• Professional fluency in German and English