Quality Operations Senior Specialist – Sterile Manufacturing

gloor & lang Pharma and Biotech Recruiting; Neuenburg; On-site; CHF 95,000 - 120,000; Full time

Job summary

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

We require hands-on GMP quality experience, batch release expertise, and strong English skills (C1–C2); German or French language skills are advantageous as an asset.

Qualifications

• BSc/MSc or equivalent in a scientific or pharmaceutical discipline.
• Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance.
• Hands-on experience in sterile / aseptic manufacturing is required.
• Experience with batch record review and batch release / product disposition.
• Solid knowledge of GMP quality processes: deviations, investigations, CAPAs, change controls.
• Experience with biologics drug product or External Manufacturing is a plus.
• SAP and electronic QMS familiarity is beneficial.
• Ability to work independently and learn within Quality Operations.
• Strong analytical skills and a structured, quality-focused approach.
• Excellent English (C1–C2); German or French language skills are advantageous.

Responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing.
• Review batch documentation and support batch release / product disposition.
• Review and assess deviations, investigations, CAPAs and change controls.
• Ensure compliance with cGMP and regulatory standards.
• Review quality and validation documentation and identify potential compliance gaps.
• Collaborate with external manufacturers and internal teams to resolve quality issues.
• Support inspection and audit readiness activities.
• Maintain quality/disposition information in applicable systems.
• Escalate quality or compliance risks as needed.
• Contribute to continuous improvement and other product quality activities.

Skills

Quality Operations

Sterile Manufacturing

Batch Release

GMP Compliance

Quality Assurance

Deviations

CAPAs

SAP

Electronic QMS

Education

BSc/MSc in science or pharmaceutical discipline

Tools

SAP

Electronic Quality Management System

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.