Product Quality Expert
Vor 6 Tagen
**About the role**:
As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.
The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External inspections and internal audits, Quality projects.
**How you will contribute**:
Regulatory compliance:
- Be responsible for biological product manufactured on site and act as an expert for all the topics related to regulatory compliance for this product.
- Prepare Product Quality Reviews (PQR) for products manufactured at the Neuchâtel facility, annually and according to health authority requirements.
- Review global release specifications, ensuring the implementation of correct updated versions for products manufactured at Neuchâtel facility.
- Participate in GMP (Good Manufacturing Practice) tours of facility to ensure inspection ready status.
Interaction with authorities:
- Act as a “Subject Matter Expert” (SME) in the creation and modification of regulatory license sections for products manufactured in Neuchâtel (clinical phase III and commercial).
- Manage/prepare the necessary supportive documentation for regulatory submissions and for major change projects in Neuchâtel facility.
- Prepare/Review documentation for change controls, audit observations and regulatory agency questions.
- Support/Write the responses to regulatory agency questions, and if necessary, facilitate the collaboration among several Subject Matter Experts to achieve the required documentation.
External inspections and internal audits (corporate):
- Supports the preparation of the inspections.
- Supports the preparation of pre-required documents.
- Participates in audits and inspections as required (back room or inspection room).
- As part of the quality matrix team, helps to define of the strategy of responses to health authority questions.
- Updates all records relative to the inspection in TrackWise when necessary.
- Proposes improvement initiatives to simplify and streamline the tasks described above.
Routine and Quality Projects:
- Assist in preparation and review of all quality documentation as required.
- Participate in Quality Council meetings as necessary.
- Support the coordination of site Key Performance Indicators (KPIs).
- Participate in project teams when necessary.
- Participate in product launch activities.
- Identify opportunities to improve quality processes.
- Collaborate with the global Quality Product Leads and Regulatory Affairs partners.
**What you bring to Takeda**:
- University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
- At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry
- Experience in writing and/or reviewing eCTD licenses (quality - module 3) is an asset
- Experience with the regulatory affairs framework is an asset
- Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, Quality system standards and data integrity principles
- Experience as a change owner or project leader
- Knowledgeable in GMP inspections and management of regulatory / quality standards
- Fluent in English, and French
- Knowledge/Experience with quality tools such as Trackwise, Veeva, eCTD viewer
- Good analytical skills and ability to simplify the complex
- Problem solving oriented
**What Takeda offers you**:
- Competitive salaries.
- Full accident coverage.
- Participation in health insurance premiums.
- Advantageous pension plans.
- Subsidised meals.
- Financial participation in employee sports activities.
- Transport: support for local public transport passes, free parking, car sharing programme.
- Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and to future generations.
**Learn more about Takeda Neuchâtel**:
- With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted and committed to its local ecosystem._
- Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production._
**"Empowering our people to shine”**:
- Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, sexual orientation, gender identity, gender expression, parental status, national origin, age, disabilit
-
Quality Product Expert
vor 2 Wochen
Basel, Schweiz Takeda Pharmaceutical Vollzeit**Quality Product Expert - 8 Month Contract** **About the role**: The objective of this position is to provide expertise and appropriate documentation needed for the life cycle of the products being produced entirely or partially in the Neuchâtel facility for routine activities and improvement initiative projects. The job holder will be part of the Quality...
-
Quality Assurance Expert
vor 4 Wochen
Basel, Schweiz Takeda Pharmaceutical VollzeitTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading...
-
Basel, Schweiz Lonza VollzeitSwitzerland, Basel - Switzerland, SteinRandstad Inhouse Services is looking for a Quality Assurance Expert Compliance, Drug Product Services (M/F/d) for Lonza AG (100%). Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how they do it. Their greatest scientific...
-
Associate Director, Product Quality Lead, Quality
vor 4 Wochen
Basel, Schweiz Moderna VollzeitThe Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...
-
Product Quality Lead
vor 2 Wochen
Basel, Schweiz Sobi Vollzeit**Company Description** At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.** The Product Quality Lead provides...
-
Basel, Basel-Stadt, Schweiz Sobi, Inc VollzeitAbout the RoleAs a key member of our team, you will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance of supplier management teams. You will act as the single point of contact for external suppliers, overseeing manufacturing quality, ensuring adherence to GMP & GDP regulations,...
-
Quality Manager Combination Products
vor 3 Wochen
Basel, Schweiz Skillhubs VollzeitOur client is looking for a **Quality Manager**. **The role** In this pivotal role, you will be responsible for providing compliance oversight associated with **medical devices** and **combination product **development and manufacturing processes internally or at contract manufacturing organizations (CMOs). Performs quality assurance responsibilities for...
-
Quality Control Expert Basel
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitAbout the RoleWe are looking for a highly motivated and experienced Quality Control Expert to lead our QA efforts in Basel, Switzerland. As a Senior QA Lead, you will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs).ResponsibilitiesDevelop and implement QA strategies to ensure compliance with GMP...
-
Quality Assurance Expert Analytics, Drug Product
vor 3 Wochen
Basel, Schweiz Lonza VollzeitSwitzerland, Basel Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let...
-
Product Quality Manager
vor 1 Woche
Basel, Schweiz Lionstep AG VollzeitOn behalf of **EM Microelectronic-Marin SA**, we are searching for their next **Product Quality Manager (f/m/d)**. **Job Summary** Are you on the lookout for an exciting opportunity as a Product Quality Manager and Core Tool Champion (f/m/d) where you can make a high impact, and unlock personal and professional growth? Then keep on reading! We have...
-
Director, Product Quality Lead
vor 1 Woche
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....
-
Product Quality Lead
vor 2 Wochen
Basel, Schweiz Coopers Group AG VollzeitProduct Quality Lead For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team! As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to...
-
Product Quality Manager
vor 3 Wochen
Basel, Schweiz EM Microelectronic-Marin SA Vollzeit**We work directly on behalf of EM Microelectronic-Marin SA and do not charge any agency fees.** **What this position has to offer**: - High impact role with significant visibility and challenges - Opportunity to create and empower the organization with automotive expertise - Personal and professional growth opportunities - Collaborative and innovative...
-
Product Quality Assurance Specialist
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitJob Description:We are seeking a highly motivated and experienced QA Manager to join our team in Basel. As a preferred supplier for F. Hoffmann-La Roche Ltd., we require a professional with excellent leadership skills, strong analytical thinking, and the ability to work collaboratively within cross-functional teams.Responsibilities:Ensure compliance with...
-
Regulatory Quality Assurance Expert
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) VollzeitJob Summary:We are seeking a highly experienced Clinical Quality Assurance Manager to lead our quality assurance efforts in the area of Investigational Medicinal Products. As a member of our team, you will have the opportunity to work closely with cross-functional teams to ensure the quality and compliance of our products.Key Qualifications:Bachelor's degree...
-
Device and Combination Product Quality Manager
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitAbout the Job:The TN Switzerland company seeks a talented Device and Combination Product Quality Manager to lead our quality assurance efforts. This role requires a deep understanding of medical devices and combination products.Key Responsibilities:Serve as the single point of contact for allocated Device Development projects.Collaborate with QA...
-
Quality Systems Expert
vor 2 Wochen
Basel, Schweiz Takeda Pharmaceutical Vollzeit**About** the **role**: The Quality System Expert is responsible for supporting the Quality Systems group from an Administrator/Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (Deviation, CAPA, Change control, Complaint,...
-
Product Owner, Gcrg Data Quality
vor 3 Wochen
Basel, Schweiz UBS VollzeitSwitzerland - Zürich Business management, administration and support, Management and Business Support, Product Management and Development Group Functions **Job Reference #** 255240BR **City** Zürich **Job Type** Full Time **Your role** Do you have an entrepreneurial mindset and are you eager to understand and fulfill our clients’ needs? Do you...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Coopers Group AG VollzeitAre you currently looking to grow professionally and want to join an innovative and future-thinking organization based in Switzerland? If so, no need to look further. **Product Quality Lead** As Product Quality Lead you are the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products. **As...
-
Quality Assurance Expert
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Altogen VollzeitAbout CompanyALTOGEN SWITZERLAND is a Swiss engineering and consulting company specialized in life sciences. The company has proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise, and project coordination, ALTOGEN supports partners throughout all areas of product life cycles. Since its...
