GxP Regulatory Process Lead
vor 11 Stunden
Gloor&lang AG is seeking an experienced professional to join their Global QA Team as a Senior QA Process Manager - Biopharmaceuticals. This 8-month contract position will focus on providing leadership and support for GxP regulated processes within the company's biopharmaceutical division.
About the Role:
- Support proactive identification of needs for process standardization, regulatory compliance direction, and areas for improvement
- Raise awareness and understanding of process requirements to senior management and cross-functionally
- Develop process improvement needs from deviation trends, audit findings, and inspection reports to drive corrective and preventative actions
- Leverage process excellence methodologies to drive continuous process improvement
Your Profile:
- > 3-5 years of experience in Pharma QMS, QA, Manufacturing, and/or RA
- Experience in GxP operational environments
- Strong Project Management skills
- Knowledgeable of KPI and performance management systems
- Experience working in international organizations
What We Offer:
A dynamic and challenging work environment with opportunities for growth and development. The ideal candidate will have a strong communication skillset, high visibility, and a proactive mindset, with experience working in international teams.
-
GxP Process Improvement
vor 15 Stunden
Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit8 months contract - CAPA - Audit - Change - Deviation--- |Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. With a strong portfolio of on-market products, and an extensive...
-
Process Excellence Specialist GxP
vor 7 Stunden
Basel, Basel-Stadt, Schweiz gloor&lang AG VollzeitSenior QA Process Manager - Biopharmaceuticals ContractGloor&lang AG invites applications for an 8-month contract Senior QA Process Manager - Biopharmaceuticals position within their Global QA Team. As a key member of the team, you will be responsible for providing leadership and support for GxP regulated processes.About the Job:You will play a crucial role...
-
Digital Manufacturing Process Leader
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitWe are seeking a Senior MES Implementation Specialist to drive our digital transformation journey in manufacturing processes.About the Role:This is an exciting opportunity to shape state-of-the-art MES solutions and contribute to cutting-edge digitalization initiatives.Responsibilities:Lead the implementation of MES systems and processes to ensure optimal...
-
Reporting Process Improvement Lead
vor 1 Tag
Basel, Basel-Stadt, Schweiz dotCommunity Sp z o. o. VollzeitRole DescriptionThis role focuses on improving the quality, accuracy, and traceability of regulatory returns while ensuring full compliance with regulatory requirements. The ideal candidate will have a deep understanding of regulatory requirements, including EBA prudential returns, reporting production processes, risk assessment, and remediation...
-
Product Owner
vor 20 Stunden
Basel, Basel-Stadt, Schweiz Jobline GmbH VollzeitAbout the RoleAs a Product Owner at Jobline GmbH, you will play a pivotal role in catalyzing global development and execution of PT's Digital and Operational Excellence strategy. You will partner with customers across PT functions to drive the delivery of a key digital initiative in the Regulatory, Supply Chain, and Quality domains.Key Tasks:Digital...
-
Regulatory Affairs Lead
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitWe are seeking a seasoned Regulatory Affairs professional to join our team as Associate Director, Regulatory Affairs Small Molecules. In this role, you will provide regulatory guidance and strategic direction to internal and external stakeholders for our Small Molecules business.Your key responsibilities will include partnering with internal and external...
-
Regulatory Return Remediation Expert
vor 1 Tag
Basel, Basel-Stadt, Schweiz dotCommunity Sp z o. o. VollzeitJob OverviewWe are looking for an experienced Regulatory Reporting Remediation Specialist to join our team in Europe. As a key member of our IRR Programme, you will play a crucial role in delivering regulatory reporting outcomes.The successful candidate will have a strong background in regulatory reporting, with experience in reviewing and remediating...
-
GxP Compliance Consultant
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitRequirements and QualificationsThe successful candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a team environment.Candidates must provide Criminal record extract not older than three monthsFluent in English and German (spoken & written)Big pharma experience, document creation experience, GxP,...
-
Basel, Basel-Stadt, Schweiz dotCommunity Sp z o. o. VollzeitAbout the RoleIn this position, you will support the delivery of regulatory reporting outcomes by working closely with our IRR Programme Director for Europe. We are seeking an experienced and detail-oriented Regulatory Reporting Remediation Specialist to join our team.The ideal candidate will have a deep understanding of regulatory requirements, including...
-
Regulatory Content Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Sobi VollzeitSobi is a leading international pharmaceutical company that specializes in developing treatments for rare disease patients.Job OverviewThe Global Labeling Operations Lead will be responsible for managing and executing activities related to the approval and maintenance of printed labeling components, including packaging mock-ups and patient information...
-
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitBusiness Analysis Lead:We are seeking a highly skilled and experienced Associate Director Scientific Business Analysis to lead our Project Insights product line within Novartis Biomedical Research Informatics as a Business Analyst and Product Line Partner.This is an exciting opportunity to execute on every aspect of planning, design, development, and...
-
Senior QA Process Manager
vor 3 Stunden
Basel, Basel-Stadt, Schweiz gloor&lang AG VollzeitSenior QA Process Manager - Biopharmaceuticals Contract OpportunityGloor&lang AG seeks a seasoned professional to fill an 8-month contract Senior QA Process Manager - Biopharmaceuticals position within their Global QA Team. As a key member of the team, you will provide leadership and support for GxP regulated processes.About the Position:In this role, you...
-
Regulatory Submission Coordinator
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitAbout UsWe are a company that values quality and people in every aspect of our work. Our purpose-driven team utilizes technology and human-centric approaches to drive impactful results.Job ResponsibilitiesThe Regulatory Affairs Specialist will manage regulatory submissions, ensure alignment with Notified Bodies, and support product safety and efficacy for...
-
Scientific Regulatory Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitJob Overview:Role Summary:TN Switzerland is seeking a highly skilled Scientific Regulatory Expert to join our team in the biocides sector.The successful candidate will be responsible for providing regulatory and technical expertise to support the development and implementation of strategies for the approval of new and existing active substances at community...
-
Global Regulatory Strategist
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz dsm-firmenich VollzeitSucceed in a Global EnvironmentWe're seeking a seasoned Global Regulatory Strategist to drive our regulatory affairs strategy forward. As a key player in our Regulatory Affairs team, you will be responsible for developing and implementing effective regulatory strategies across our flavors portfolio, with a focus on the EMEA region.Your Key...
-
Regulatory Affairs Specialist
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitJob Description:Role Summary:As a Regulatory Affairs Specialist - Biocides, you will play a crucial role in supporting the development and implementation of regulatory strategies for the approval of new and existing active substances at community level and the authorisation of biocide products on a national, EU and global basis.You will work closely with...
-
Senior Biocide Regulatory Advisor
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitJob Role:Senior Biocide Regulatory Advisor:Our team is seeking a highly experienced Senior Biocide Regulatory Advisor to join us in the biocides sector.As a key member of our team, you will be responsible for providing regulatory and technical expertise to support the development and implementation of strategies for the approval of new and existing active...
-
Regulatory Submission Manager
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAbout the RoleWe are looking for a talented Regulatory Submission Manager to join our team. The successful candidate will have a strong background in regulatory affairs and experience in managing submission processes. They will be responsible for preparing regulatory submission dossiers, providing data visuals, and contributing to the development of key...
-
Section Head of Process Chemistry
vor 2 Wochen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitSynthetic Molecules Technical Development Department OpportunityJob Description:The Synthetic Molecules Technical Development department at Roche has an opening for a Section Head of Process Chemistry & Catalysis.This role involves leading a team responsible for end-to-end process chemistry, from designing new synthetic routes to developing commercial...
-
Regulatory Reporting Specialist
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Infosys Limited VollzeitAs a senior member of our team, you will play a key role in driving the development of regulatory reporting solutions for our clients. Your extensive experience in the financial services industry and strong understanding of business, technology, and operations will enable you to navigate complex regulatory landscapes and identify opportunities for...