Specialist Compliance DSP

Incyte; Yverdon-les-Bains; On-site; CHF 110,000 - 150,000; Full time

Job summary

Incyte in Switzerland seeks a Compliance Specialist to manage deviation, CAPA and risk management. You will support cGMP and site quality goals in manufacturing, lead continuous improvement projects and review manufacturing documents to ensure compliance.

The role requires 3–5 years in biotech quality with strong analytical skills, and fluency in English and French. You will mentor the DSP manufacturing team and ensure adherence to GMP guidelines.

Qualifications

• 3–5 years in biotech with cGMP drug manufacturing and quality responsibility.
• Experience with deviation management, CAPA and investigations.
• FMEA, root cause analysis and related quality tools are required.

Responsibilities

• Ensure systems are inspection-ready at all times.
• Raise, investigate, assess and close deviations within timelines.
• Define and plan CAPA for recurrence prevention and process improvement.
• Define and plan effectiveness checks for improvements.
• Manage Change Controls and ensure regulatory compliance.
• Develop KPI for manufacturing quality and operations performance.
• Act as SME during health authorities inspections and present CAPAs.
• Coach and train staff on GMP guidelines and SOPs.

Skills

FMEA

Root Cause Analysis

Quality Assessment Tools

Training & SOP Review

Team Collaboration

Biotech cGMP knowledge

English & French proficiency

Education

BSc/Master/Engineering in Pharma/Biotech

Job description

Overview

SUMMARY

The compliance specialist is responsible for managing compliance related topics including deviation management, CAPA, risk management, change control, training and batch record review.

The compliance specialist will support cGMP and site quality compliance goals within manufacturing department. He/She will also manage continuous improvements and efficiency projects

Duties And Responsabilities

• Ensure that the systems are ready for inspection at all time
• Raise, investigate, assess and close Deviation within timelines
• Define and plan CAPA to avoid recurrence and allow process improvement.
• Define and plan effectiveness check
• Manage Change Controls Process as compliance resolution or for continuous improvement.
• Define and maintain KPI for manufacturing support group regarding quality and operational performance
• Act as SME during Heath Authorities inspection by presenting Risk Aassessment, Deviations, Investigations, CCP and CAPAs
• Develop and maintains business KPI’s and proposes/supports continuous improvements
• Author, review and approve SOP/WI or any manufacturing supporting document
• Act as a mentor to DSP manufacturing team members and lead by example to ensure integration of good manufacturing practices
• Coach and train Manufacturing Staff to GMP guidelines and sub-departement specific SOP
• Provide Training Polyvalence Overview within sub-department
• Proactively propose problem resolution to process and DSP equipment
• Review and support the review of executed batch report (exception review)
• Implement quality compliance initiatives in the department in collaboration with QA
• Coach and support other team members for quality compliance matters (such as deviation and changes management)
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Delegate to: DSP Manager / Process Support Manager

Requirements

• BSc, Master or Engineering Degree in Pharma/Biotech engineering
• Relevant experience in biotech industry related to cGMP drug manufacturing and quality.
• Direct experience in FMEA, root cause analysis, and associated quality assessment tools
• Typically minimum 3-5 years of experienceAbility to work in a fast paced – high regulated environment
• French and English (Fluent)
• Team work oriented mindset