Specialist Quality Operations

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Incyte is seeking an experienced Quality Operations professional to oversee GMP manufacturing quality at our Yverdon-les-Bains facility in Switzerland. You will manage daily QA activities, review batch records, ensure cGMP compliance, and drive CAPA and continuous improvement across manufacturing areas.

The role requires a relevant science degree, a minimum of 3 years in pharma Quality Operations, strong knowledge of cGMPs and regulatory expectations, and fluent French with English as a plus.

Qualifikationen

• Academic degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering).
• Minimum 3 years' experience in Quality Operations for pharmaceuticals at manufacturing sites.
• Thorough knowledge of cGMP and international regulatory requirements.
• Understanding of Biotech processes.
• Experience dealing with international inspections.
• Strong analytical and problem-solving skills.
• Good verbal and written communication skills with a structured communication style.
• Compliance-focused; internal auditor qualifications are an asset.
• Fluent in French (written and spoken) and ideally good level in English.

Aufgaben

• Manage day-to-day quality oversight of USP and DSP manufacturing, washing area, and media/buffer solutions preparation activities.
• Perform Batch Record reviews within defined timelines and recommend batch disposition.
• Review and approve manufacturing SOPs to ensure process efficiency and regulatory compliance.
• Ensure compliance of manufacturing activities with cGMPs and approved procedures.
• Ensure compliance of manufacturing documentation management (logbooks, batch records, FORMs).
• Review and approve Master Batch Records for manufacturing.
• Review and approve deviations and investigations; escalate major/critical issues.
• Recommend and approve CAPA plans and ensure timely implementation.
• Ensure compliance regarding materials management in production (traceability, identification).
• Review, assess and approve changes in area of responsibility; contribute to risk assessments.
• Contribute to continuous improvement initiatives in area of responsibility.
• Perform GMP tours (GEMBA) and track action implementation.
• Represent QA in manufacturing routine operational meetings.
• Foster compliant and right-first-time operations.
• Collaborate with manufacturing to prevent issues and manage unexpected events.
• Promote understanding and application of cGMPs by BioPlant employees.
• Partner with internal stakeholders for efficient collaboration.
• Interpret GMP and regulatory requirements and ensure implementation as applicable.

Kenntnisse

Quality operations

cGMP knowledge

Regulatory inspections

Biotech processes

Analytical thinking

Problem solving

Communication skills

French (written & spoken)

English language

Ausbildung

Bachelor's degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering)

Internal auditor qualification

Jobbeschreibung

Overview

Summary: The role will be responsible for the quality oversight of the manufacturing of monoclonal antibody(ies) produced at Incyte large scale biological manufacturing facility at Yverdon-les-bains, Switzerland. The role will cover all manufacturing departments.

The role will ensure a strong collaboration with other Bioplant functions and will promote compliance and continuous improvement while supporting the on-time supply products.

Duties And Responsibilities

• Manage the day-to-day quality oversight of the USP and DSP manufacturing, washing area and media/buffer solutions preparation activities (including on the floor presence in manufacturing classified area)
• Perform Batch Record reviews within defined timelines and recommend batches disposition
• Review and approve manufacturing SOPs to ensure efficiency of the process and compliance with Incyte Policies and regulatory requirements
• Ensure compliance of manufacturing activities with cGMPs and approved procedures
• Ensure compliance of manufacturing documentation management (logbooks, paper batch records, FORMs...)
• Review and approve manufacturing Master Batch Records
• Review and approve manufacturing deviations and investigations. Escalate as appropriate to management major/critical issues
• Recommend and approve CAPA plans and ensure timely implementation
• Ensure compliance regarding materials management in production (traceability, identification)
• Review, assess and approve implementation of changes in the area of responsibility
• Contribute to the elaboration of risk assessment in the area of responsibility
• Contribute to the continuous improvement initiatives in the area of responsibility
• Perform GMP tour / GEMBA and track action implementation
• Represent QA function in manufacturing routine operational meetings
• Foster compliant and right first time operations
• Operate in close proximity with manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events
• Foster the understanding and the application of Good manufacturing Practices (cGMPs) by BioPlant employees
• Partner with internal stakeholders to ensure efficient collaboration
• Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable
• Performs all responsibilities in accordance with company policies , policies, procedures, applicable regulations and safety requirements
• Stay current with the applicable regulations and promote Quality across the Incyte organization
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guideline

Requirements

• Academic degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering)
• Firsthand experience of min 3 years in Quality Operations for pharmaceuticals at manufacturing sites
• Thorough knowledge in cGMP and international regulatory requirements
• Understanding of Biotech processes
• Experience in dealing with international inspections
• Strong analytical and problem solving kills
• Good verbal and written communication skills with well structured communication
• Compliance focused
• Internal auditor qualification is an asset
• Fluent in French written and spoken (the company language) and ideally good level in English

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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