Project Manager Global Launch Projects Partner Markets jobs at Incyte in Switzerland

The manager will ensure QA deliverables related to classified rooms and utilities qualification, filling line validation, and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements, including Eudralex GMP Annex 1.

DUTIES AND RESPONSIBILITIES

Project phase – Design, Qualification & Commissioning

·Act as the QA lead in engineering projects involving aseptic filling line, isolator and cleanroom infrastructure.

·Ensure early QA involvement in design and risk assessments, embedding GMP, Annex 1 and data integrity principles into system architecture and process flow.

·Oversee and approve qualification activities (FAT/SAT, IOPQ), ensuring quality requirements are met prior to operational release.

·Lead the QA assessments of change controls and ensure traceability from design to execution.

·Drive quality risk management throughout the project lifecycle supporting a right first-time approach in commissioning and validation

·Support the development and approval of GMP documentation, including SOPs, master batch records and protocol required for the new process or equipment.

·Ensure Annex 1 alignment by integrating contamination control principles, Contamination Control Strategy elements and aseptic process simulation requirements into project deliverables.

·Represent the QA function in project meetings to ensure alignment with technical and regulatory expectations.

Operational phase – Aseptic Manufacturing Operations

·Lead the QA activities related to aseptic filling ensuring compliance with Annex 1 and GMP requirements.

·Ensure timely review and approval of SOPs, deviations, CAPAs, change controls and batch records, maintaining product release timelines and quality standards.

·Be the primary QA contact during regulatory inspections and internal audits, demonstrating mastery of aseptic quality systems and facility knowledge.

·Lead by example in the cleanroom environment and foster an aseptic mindset, supporting all team members in maintaining the highest standards of sterility assurance

·Analyze Quality KPIs, lead continuous improvement initiatives and escalate quality trends to management

·Support Inspection readiness activities and represent QA function for engineering and manufacturing related matters in Health Authorities inspections

·Collaborate with cross-functional teams, including production, engineering, and manufacturing sciences, to drive quality and operational excellence.

·Promote a culture of compliance and continuous improvement throughout the project lifecycle.

·Ensure all activities comply with safety requirements, company policies, and applicable regulations.

REQUIREMENTS

·Demonstrated experience in qualification, validation and GMP operations.

·Significant experience in aseptic process activities (experience in isolator technology is an asset). Candidates with equivalent relevant experience are encouraged to apply

·Extensive experience in Quality Assurance oversight of pharmaceutical manufacturing projects. Candidates with equivalent relevant experience are encouraged to apply.

·Academic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering, or related field).

·Strong knowledge of cGMP and international regulatory requirements for facility qualification and process validation.

·Strong knowledge of Eudralex GMP Annex 1 and Sterility Assurance concepts.

·Strong analytical and problem-solving skills.

·Excellent verbal and written communication skills with a structured approach.

·Fluent in French (written and spoken); proficiency in English is an asset.

·Ability to work independently and collaborate with multidisciplinary teams.

The aforementioned activities can be delegated to the QA Manager Tech. Transfer, to the QA Manager Operations and Engineering and to the QA Associate Directors.

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Responsibility for managing and maintaining existing development and marketing authorization dossiers and compiling submissions in compliance with ICH specifications and Health Authority regulations globally. Co-ordination with functional leads in various disciplines to ensure compliant documents, maintain regulatory information and the physical and electronic regulatory archives, mentor on eCTD requirements and other duties and/or special projects as assigned or required.

Duties and Responsibilities

·Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.

·Ensures documents comply with submission ready standards and guidelines and provides guidance with respect to requirements.

·Maintains and archives all regulatory correspondence in appropriate systems.

·Liaises with vendors for submission support, as needed.

·Participates in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.

·Provides expertise and support to the user community for RIM systems and EDMS.

·Maintains tracking tools and systems for regulatory information, including submission content plans.

·Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.

·Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.

·Mentors others on submission processes and requirements and may manage contract Regulatory Operations personnel.

·Contribute positively to a strong culture of business integrity and ethics.

·Act within compliance and legal requirements as well as within company guidelines.

·Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports, etc.).

·Participates in the preparation of dossiers containing manufacturing, preclinical, and clinical data.

·Provides guidance to authors for clear document and data presentation and location in order to optimize submission navigation as well as the regulatory review and approval process.

·Analyze and continuously improve work practices and guidelines and organize and conduct training on behalf of the Regulatory Operations team as appropriate.

·Remain current on knowledge of industry trends relevant to global electronic submissions and interface systems with Health Agencies for all regions

Requirements

·Bachelor degree (in science, technology, health- related field, or business management preferred) or equivalent experience.

·Relevant experience in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.

·Experience in drug development and knowledge of global regulatory submission content and formats.

·Experience with packaging and labelling, and combination products submissions preferred.

·Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins.

·Excellent organization, communication and writing skills.

·Ability to manage multiple priorities and projects.

·Strong attention to detail and quality.

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Senior Cybersecurity Architect is responsible for developing security architecture across all technology stacks, including on-premises, cloud (AWS / Azure / SaaS) environments. This role requires hands-on technical skills needed for evaluating, selecting, implementing and managing cybersecurity tools and technologies. It also needs working closely with business, infrastructure, and other IT teams to assure security for a variety of technology solutions. s. Additionally, the Senior Cybersecurity Architect will manage consulting resources and lead projects to ensure the organization’s security posture aligns with industry best practices and organizational goals.

***This is a 4-day on-site position***

Essential Functions of the Job (Key responsibilities)

·Develop cybersecurity architecture, ensuring alignment with organizational goals and industry best practices across all technology stacks, including on-premises, cloud, to manage current and merging security risks.

·Lead the evaluation and selection, implementation and management of comprehensive security solutions, ensuring robust protection for the organization’s assets.

·Conduct vulnerability assessments, penetration testing, and security reviews, collaborating with various teams on remediation efforts.

·Provide expert guidance on security controls and best practices for both on-premises and cloud-based solutions to IT and business teams.

·Perform detailed security investigations, document findings and recommendations for complex incidents, and resolve issues while preserving forensic evidence.

·Identify and implement continuous improvements in security-related processes and technologies.

·Mentor other cybersecurity professionals in the team, to upskill them to meet the organizational requirements

·Lead and manage cybersecurity projects, ensuring timely delivery and alignment with organizational objectives.

·Collaborate with the Security Operations Center (SOC) and other teams to enhance detection and response capabilities.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·7 - 10 years of experience in IT with a focus on Cybersecurity and Cloud security services.

·4+ years of Cloud Security architecture experience.

·Relevant certifications (e.g., CISSP, CCSP, AWS/Azure Certified Security Solutions architect) preferred.

·Proven experience in managing and leading cybersecurity teams and projects.

·Extensive knowledge of networking protocols and technologies, network security architecture, and engineering.

·Expertise in cloud (AWS andAzure) and on-premises security and related technologies.

·In-depth knowledge and experience with various security tools and technologies, including End-Point Security, SIEM, DLP, IRM, vulnerability assessment, and patch management.

·Comprehensive understanding of risk and vulnerability mitigation.

·Knowledge of security standards and guidelines from NIST and SANS.

·Extensive hands-on administrative experience with infrastructure and/or automation tools including but not limited to Windows/Linux and other OS and/or modern cloud service plans.

·Basic knowledge of ITIL.

·Strong project management skills, including experience with project planning, execution, and monitoring.

·Excellent relationship-building skills with both internal and external stakeholders.

·Strong organizational and communication skills.

·Must be a self-starter and work well independently, as well as within a team environment.

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

is responsible for Microbiological Quality Control (QC) activities to support product testing (IPC, DS, DP), environmental and utilities monitoring, aseptic processes, and coordination of outsourced potency assay, microbial and viral safety testing, including cell-based assays and microscopy-based methods. This role ensures activities are conducted in compliance with cGMPs, regulatory expectations, and internal quality standards.

Key Responsibilities

• Act within compliance and legal requirements, as well as within company policies and procedures.
• Lead all microbiological QC activities including: Environmental Monitoring (EM) and Clean Utilities Sampling/Testing (UTY), In-process Control (IPC) and Drug Substance/Drug Product (DS/DP) microbiological testing, Aseptic process monitoring and support to sterility assurance
• Responsible for Aseptic Process Simulation (APS) testing activities, ensuring compliance with sterility assurance and regulatory expectations.
• Manage incoming control testing of media and plates for APS.
• Responsible for the sampling and monitoring of clean utilities and controlled environments.
• Oversee and coordinate outsourced testing for: Sterility, Mycoplasma, Viral safety, and Cell-based assays
• Oversee and coordinate microbiological method verifications and tech transfer and ensure laboratory readiness for new products/processes.
• Ensure timely and accurate review/approval of microbiology-related protocols, reports, SOPs and work instructions.
• Actively participate in inspections by Health Authorities and ensure readiness of the microbiology team.
• Support purchase requisitions and follow-up of purchase orders to ensure business needs are met in a timely manner.
• Create a positive, collaborative, and high-performance team environment aligned with Incyte values.
• Lead the microbiology QC team, ensuring proper resource allocation, clear team plans, and effective execution of lab activities.
• Manage performance, provide coaching, technical guidance and career development support to team members.
• Assign training requirements and monitor training status for the team to ensure compliance and continuous learning.
• Lead microbiology deviation management, investigations, CAPAs, and participate in cross-functional root cause analyses.
• Ensure appropriate qualification and maintenance of microbiological QC equipment.
• Act as Quality Champion for the microbiology QC group, ensuring a high level of compliance, ownership, and inspection readiness.
• Lead implementation of 5S and Lean practices in the microbiology laboratory.
• Monitor and report microbiology-related quality indicators and contribute to department budget planning.
• Ensure all QC activities comply with cGMPs and HSE policies, and foster a safety-first culture.

Requirements

• Significant experience in microbiology QC within a GMP biotech environment, including substantial leadership experience (typically demonstrated by 10+ years in the field and 5+ years in a leadership role, or equivalent combination of education, training, and experience).
• Strong knowledge of GMP microbiology, aseptic practices, and environmental monitoring.
• Proven experience managing teams and fostering development and collaboration.
• Experience in adventitious agent testing and coordination of external labs.
• Ability to interact effectively with Health Authorities and lead teams through inspections.
• Strong project management, organizational, and cross-functional communication skills.
• Proficiency in quality systems (deviation, CAPA, change control).
• Fluent in French and English.
• MSc or equivalent degree in microbiology, biotechnology, or related scientific discipline.

Energies, Envionment, Health & Safety

• We promote working conditions that respect sustainable development and Incyte's ethical values, with an emphasis on health, well-being and reducing our environmental impact.
• We ensure the efficient use of our resources and systems, with the aim of optimizing and increasing our energy performance.
• We are committed to identifying, recording, preventing and actively reducing all risks to the health and safety of our employees, through continuous improvement of our processes.
• Respecting, promoting and implementing the EEHS policy is an integral part of every function.

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

We are seeking a highly motivated and experienced Senior Manager / Manager Manufacturing Fill & Finish to lead the aseptic manufacturing activities on a state-of-the-art multi-format filling line (vials, syringes, and cartridges) operated under isolator technology. The role includes a strong project phase involvement as System and Area Owner and will evolve into full operational responsibility as leader of the Fill & Finish team. This position requires a solid background in aseptic filling manufacturing, GMP Operations, operational excellence and people management.

Project Phase:

• Act as System Owner for the installation and qualification of the new filling area, aseptic filling line and related surrounding process equipment
• Responsible to define and implement the operational procedures (SOPs) for aseptic activities under isolator.
• Define material introduction processes in clean rooms, set-up, filling batches, and set-down operations.
• Support APS protocols preparation and execution of protocols and reports in collaboration with validation and QA teams.
• Participate in visual inspection activities definition and support visual inspection readiness.

Operational Phase:

• Manage, plan, lead all GMP productions
• Oversee day-to-day aseptic filling operations, ensuring adherence to GMP, safety, and quality standards.
• Manage the planning and scheduling of filling activities, ensuring resource optimization and batch readiness.
• Ensure compliance with all applicable procedures, regulations, and internal quality systems.
• Assess and investigate events, deviations and non-conformances in Fill & Finish manufacturing activities
• Operational budget defintion and follow-up
• Define and maintain KPI for Fill & Finish activity regarding EHS, quality, operational performance and support the tracking of Manufacturing performance metrics
• Drive continuous improvement initiatives focused on efficiency, compliance, and safety.
• Support new process and new formats implementation, including APS.
• Lead and manage Change Controls and deviations including any corrective actions
• Proactively propose problem resolution to process
• Execute and support development/ equipment qualification/ validation activities for new equipment/ new process
• Representative as SME during GMP inspection
• Provides technical leadership for DP Manufacturing
• Remain current on latest industry standards
• Ensure safe working conditions
• Contribute positively to a strong culture of business integrity and ethics
• Lead local improvements projects and initiatives in collaboration with other Bioplant departments and Global functions
• Provide appropriate reporting in term of quality and frequency
• Act actively to the people development
• Act within compliance and legal requirements as well as within company guidelines

People Management:

• Lead, develop, and coach a team of operators and supervisors.
• Promote a culture of ownership, collaboration, and accountability within the team.
• Ensures staff is sufficiently trained to perform their job responsibilities
• Conduct regular performance reviews and career development discussions.
• Foster strong communication and cross-functional collaboration.

REQUIREMENTS

• Degree in Life Sciences, Engineering, or related field, or equivalent combination of education, training, and relevant experience.
• Significant experience in aseptic manufacturing, preferably with isolator technology (typically demonstrated by 10+ years in the field, or an equivalent combination of education, training, and experience)
• Experience in project management and installation/start-up of manufacturing equipment.
• Demonstrated leadership and team management skills.
• Strong knowledge of GMP and regulatory requirements.
• Strong experience in projects with good knowledge of Design, Construction & C&Q activities
• Excellent communication and stakeholder management abilities.
• Strong interpersonal and communications skills; written and oral
• Fluent in English and French
• Travelling may be required
• Broad knowledge of Pharmaceutical Quality, Manufacturing, GLP/GCP/GMP/GAMP practices and Annex 1 requirements

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

We are seeking a highly motivated and experienced Senior Manager / Manager Manufacturing Fill & Finish to lead the aseptic manufacturing activities on a state-of-the-art multi-format filling line (vials, syringes, and cartridges) operated under isolator technology. The role includes a strong project phase involvement as System and Area Owner and will evolve into full operational responsibility as leader of the Fill & Finish team. This position requires a solid background in aseptic filling manufacturing, GMP Operations, operational excellence and people management.

Project Phase:

• Act as System Owner for the installation and qualification of the new filling area, aseptic filling line and related surrounding process equipment
• Responsible to define and implement the operational procedures (SOPs) for aseptic activities under isolator.
• Define material introduction processes in clean rooms, set-up, filling batches, and set-down operations.
• Support APS protocols preparation and execution of protocols and reports in collaboration with validation and QA teams.
• Participate in visual inspection activities definition and support visual inspection readiness.

Operational Phase:

• Manage, plan, lead all GMP productions
• Oversee day-to-day aseptic filling operations, ensuring adherence to GMP, safety, and quality standards.
• Manage the planning and scheduling of filling activities, ensuring resource optimization and batch readiness.
• Ensure compliance with all applicable procedures, regulations, and internal quality systems.
• Assess and investigate events, deviations and non-conformances in Fill & Finish manufacturing activities
• Operational budget defintion and follow-up
• Define and maintain KPI for Fill & Finish activity regarding EHS, quality, operational performance and support the tracking of Manufacturing performance metrics
• Drive continuous improvement initiatives focused on efficiency, compliance, and safety.
• Support new process and new formats implementation, including APS.
• Lead and manage Change Controls and deviations including any corrective actions
• Proactively propose problem resolution to process
• Execute and support development/ equipment qualification/ validation activities for new equipment/ new process
• Representative as SME during GMP inspection
• Provides technical leadership for DP Manufacturing
• Remain current on latest industry standards
• Ensure safe working conditions
• Contribute positively to a strong culture of business integrity and ethics
• Lead local improvements projects and initiatives in collaboration with other Bioplant departments and Global functions
• Provide appropriate reporting in term of quality and frequency
• Act actively to the people development
• Act within compliance and legal requirements as well as within company guidelines

People Management:

• Lead, develop, and coach a team of operators and supervisors.
• Promote a culture of ownership, collaboration, and accountability within the team.
• Ensures staff is sufficiently trained to perform their job responsibilities
• Conduct regular performance reviews and career development discussions.
• Foster strong communication and cross-functional collaboration.

REQUIREMENTS

• Degree in Life Sciences, Engineering, or related field, or equivalent combination of education, training, and relevant experience.
• Significant experience in aseptic manufacturing, preferably with isolator technology (typically demonstrated by 10+ years in the field, or an equivalent combination of education, training, and experience)
• Experience in project management and installation/start-up of manufacturing equipment.
• Demonstrated leadership and team management skills.
• Strong knowledge of GMP and regulatory requirements.
• Strong experience in projects with good knowledge of Design, Construction & C&Q activities
• Excellent communication and stakeholder management abilities.
• Strong interpersonal and communications skills; written and oral
• Fluent in English and French
• Travelling may be required
• Broad knowledge of Pharmaceutical Quality, Manufacturing, GLP/GCP/GMP/GAMP practices and Annex 1 requirements

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.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .