Quality Operations Senior Specialist – Sterile Manufacturing

gloor & lang Pharma and Biotech Recruiting; Neuenburg; On-site; CHF 120,000 - 150,000; Full time

Job summary

gloor & lang Pharma and Biotech Recruiting is seeking an experienced Quality Operations professional for a 12-month temporary assignment in French-speaking Switzerland. The role focuses on sterile drug product manufacturing, batch documentation, and product disposition within an international external manufacturing environment.

The candidate will review deviations, CAPAs, and change controls, ensure cGMP compliance, and collaborate with external manufacturers and cross-functional teams to

Qualifications

• BSc/MSc or equivalent degree in a scientific or pharmaceutical discipline.
• Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance.
• Hands-on experience in sterile / aseptic pharmaceutical manufacturing.
• Experience with batch record review and batch release / product disposition.
• GMP quality processes including deviations, investigations, CAPAs and change controls.
• Experience with biologics drug product and/or External Manufacturing is an advantage.
• Excellent English skills (C1–C2) mandatory; German/French an asset.

Responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing
• Review batch documentation and support batch release / product disposition activities
• Review and assess deviations, investigations, CAPAs and change controls
• Ensure compliance with cGMP requirements, internal procedures and applicable regulatory standards
• Review quality and validation documentation and identify potential compliance gaps
• Work closely with external manufacturing partners and internal cross-functional teams to resolve quality issues
• Support inspection and audit readiness activities
• Maintain relevant quality and disposition information in applicable systems
• Escalate quality or compliance risks where appropriate
• Contribute to continuous improvement and other product quality activities

Skills

Quality Operations

Quality Assurance

Aseptic manufacturing

Batch release

GMP knowledge

CAPAs & investigations

SAP

Electronic Quality Management Systems

Analytical thinking

English proficiency

Education

BSc/MSc or equivalent in science/pharma

Tools

SAP

Electronic Quality Management Systems

Job description

12-Month Temporary Assignment | Pharmaceutical Industry | French-speaking Switzerland

For an international pharmaceutical company in the French-speaking part of Switzerland, we are looking for an experienced Quality Operations professional with a strong background in sterile pharmaceutical manufacturing and batch release activities.

The role supports Quality Operations within an international External Manufacturing environment, with a particular focus on sterile drug product manufacturing, batch documentation and product disposition. We are looking for someone who already brings relevant hands‑on Quality and sterile manufacturing experience and is ready to broaden their expertise and take on increasing responsibility within product release and Quality Operations.

Start: ASAP | Duration: 12 months

Your Responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing
• Review batch documentation and support batch release / product disposition activities
• Review and assess deviations, investigations, CAPAs and change controls
• Ensure compliance with cGMP requirements, internal procedures and applicable regulatory standards
• Review quality and validation documentation and identify potential compliance gaps
• Work closely with external manufacturing partners and internal cross-functional teams to resolve quality issues
• Support inspection and audit readiness activities
• Maintain relevant quality and disposition information in applicable systems
• Escalate quality or compliance risks where appropriate
• Contribute to continuous improvement and other product quality activities

Your Profile

• BSc/MSc or equivalent degree in a scientific or pharmaceutical discipline
• Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance
• Hands‑on experience in sterile / aseptic pharmaceutical manufacturing is required
• Experience with batch record review and batch release / product disposition
• Solid working knowledge of GMP quality processes including deviations, investigations, CAPAs and change controls
• Experience in biologics drug product and/or External Manufacturing is an advantage
• Experience with SAP and electronic Quality Management Systems is beneficial
• Ability to work independently while being willing to learn and further develop within Quality Operations
• Strong analytical skills and a structured, quality‑focused working style
• Excellent English skills (C1–C2) are mandatory
• Additional German skills are an advantage, French is an asset

You are an experienced and hands‑on Quality professional who combines a solid sterile manufacturing background with a strong interest in further developing your expertise in batch release and Quality Operations. You enjoy working across teams, take responsibility for product quality and are comfortable in an international GMP environment.