Quality Assurance and Regulatory Associate
vor 2 Monaten
Stratpharma AG, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance and Regulatory Associate to join their team. This is an exciting opportunity to work closely with the International Quality Assurance and Regulatory Director in managing the company's global quality assurance and regulatory functions.
This is a highly successful company with a strong track record of growth and expansion. They currently have a portfolio of products on the market and are committed to developing new innovative solutions.
Key Responsibilities:
- Develop, implement, and maintain quality management systems and regulatory compliance procedures.
- Provide support for internal and external audits, ensuring compliance with regulatory requirements.
- Initiate and review regulatory documents, including technical files, and provide support to the Regulatory Manager with the transition from MDD to MDR.
- Coordinate worldwide registration and compile regulatory submissions, including required legalization activities.
- Liaise with local agents and distributors to support them in their registration process.
- Maintain regulatory records and regulatory databases.
Requirements:
- 3+ years of experience in a similar role, preferably in the pharmaceutical industry.
- Strong knowledge of regulatory regulations and quality systems, including ISO13485, MDD, MDR, and MDSAP requirements.
- Experience of the pharmaceutical industry and knowledge of regulatory requirements.
- Proactive self-starter with excellent communication skills and ability to liaise effectively with stakeholders, suppliers, and distributors.
- Fluent in written and spoken English, with Spanish an advantage.
Benefits:
-
Associate Director Quality Assurance
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly experienced and skilled Associate Director Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This is a critical role that will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesQuality Management: Develop and implement quality management systems to ensure compliance...
-
Quality and Regulatory Affairs Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance and Regulatory Associate to join their team. This is a challenging global role that will work closely with the International Quality Assurance and Regulatory Director in managing the company's global quality assurance and regulatory functions.This is a highly...
-
Associate Director of Quality Assurance
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly experienced and skilled Associate Director of Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This role will be responsible for providing strategic leadership and direction to our quality assurance functions, ensuring compliance with regulatory requirements and industry standards.Key...
-
Associate Director, Quality Assurance Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Noema Pharma VollzeitAbout Noema PharmaNoema Pharma is a clinical-stage biotech company dedicated to addressing debilitating central nervous system (CNS) disorders. Our mission is to improve quality of life and patient outcomes through novel therapies.Job Title: Associate Director, Quality Assurance ManagerJob SummaryWe are seeking an experienced Associate Director, Quality...
-
Associate Director Quality Assurance
vor 1 Monat
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly skilled and experienced Associate Director Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This is a key leadership role that will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesProvide strategic leadership and direction to the Quality Assurance...
-
Senior Quality Assurance Specialist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob Title: Associate DirectorBeiGene is seeking an experienced Associate Director to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Develop and implement quality assurance strategies to ensure compliance with regulatory requirements.Lead...
-
Quality and Regulatory Associate
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitExciting Opportunity at Stratpharma AGAn ambitious forward-thinking company based in Basel has created a challenging hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company's global QA and RA functions.This is a highly successful company with impressive 200% year-on-year growth and significant...
-
Director of Quality Assurance and Compliance
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly experienced and skilled Associate Director Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This is a key leadership role that will be responsible for overseeing the quality assurance function and ensuring compliance with regulatory requirements.Key ResponsibilitiesQuality Assurance Leadership: Provide...
-
Associate Director, Quality Assurance Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Noema Pharma VollzeitAbout Noema PharmaNoema Pharma is a clinical-stage biotech company dedicated to developing innovative therapies for debilitating central nervous system (CNS) disorders. Our mission is to improve the lives of patients and their families by addressing the root causes of these conditions.Job Title: Associate Director, Quality Assurance ManagerWe are seeking an...
-
Associate Director, Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Noema Pharma VollzeitAbout Noema PharmaNoema Pharma is a clinical-stage biotech company dedicated to addressing debilitating central nervous system (CNS) disorders. Our mission is to improve quality of life and patient outcomes through innovative therapies.Job SummaryWe are seeking an Associate Director, Quality Assurance (QA) Manager – Good Manufacturing Practice (GMP) to...
-
Basel, Basel-Stadt, Schweiz Moderna Therapeutics VollzeitAbout the RoleModerna Therapeutics is seeking an experienced Associate Director, Product Quality Lead to join our Quality Assurance team. As a key member of our product team, you will oversee and ensure the quality of biological products within a franchise, managing all quality aspects of the product lifecycle from clinical production to post-market...
-
Quality Assurance Associate
vor 1 Monat
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitExciting Opportunity at Stratpharma AGAn innovative and ambitious Dermatology company based in Basel has created a challenging hybrid QARA Associate role that will work closely with the International QARA Director in managing the company's global QA and RA functions.This is a highly successful company with impressive 200% year on year growth and significant...
-
Associate Director Quality Assurance
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly skilled Associate Director Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This role will be responsible for providing support to QP activities, overseeing CMOs from a quality perspective, and ensuring compliance with EMA/MHRA and international regulations.Key ResponsibilitiesQuality Assurance Support:...
-
Quality Assurance Lead
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.Key ResponsibilitiesReview and approve SOPs, protocols, reports, and other...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.Key ResponsibilitiesReview and approve SOPs, protocols, reports, and other...
-
Associate Director of Quality Assurance
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob Summary: We are seeking an experienced Associate Director of Quality Assurance to join our team at Acadia Pharmaceuticals Inc. in a critical role that involves providing support to QP activities, overseeing CMOs from a quality perspective, and ensuring compliance with EMA/MHRA and applicable international regulations.Main Responsibilities:Quality...
-
Senior Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Noema Pharma VollzeitAbout Noema PharmaNoema Pharma is a clinical-stage biotech company dedicated to developing innovative therapies for debilitating central nervous system (CNS) disorders. Our mission is to improve the quality of life for patients and their families by addressing the root causes of these conditions.Job Title: Associate Director, Quality Assurance ManagerJob...
-
Director of Quality Assurance
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Acadia Pharmaceuticals Inc. VollzeitJob SummaryWe are seeking a highly skilled and experienced Associate Director of Quality Assurance to join our team at Acadia Pharmaceuticals Inc. This role will be responsible for providing support to QP activities, overseeing CMOs from a quality perspective, and ensuring compliance with EMA/MHRA and other international regulations.Key...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob Title: Quality Assurance ManagerAbout the Role:We are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for maintaining compliance with regulatory requirements.Key Responsibilities:Quality Assurance: Develop...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe PositionAt Roche, we are committed to delivering high-quality Investigational Medicinal Products (IMPs) to our patients in compliance with cGMP. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our manufacturing processes, analysis, and release of IMP batches.The Role of the Quality Assurance...
