Associate Director of Quality Assurance
vor 1 Woche
Job 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 Assurance Support: Provide support to QP activities as needed to ensure timely market release of Acadia product as required.
- CMO Oversight: Oversee CMOs from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.
- Quality Management System: Participate in the design, implementation, and management of the Acadia GMP quality management system, based on EMA/MHRA and other applicable international regulations.
- Regulatory Compliance: Ensure compliance of the Acadia GMP quality management system with EMA/MHRA and applicable international quality management system regulations.
- Supplier Audits: Participate in GMP supplier audits and Acadia documentation control systems as needed.
- Process Validation: Manage and/or provide oversight with CMO technology transfer, process validation, batch documentation, registration batch review, and process changes and deviations.
- Quality Agreements: Participate in the review of, and ensure conformance to, Quality Agreements with GMP contract service providers for outsourced operations.
- Continuous Improvement: Provide guidance to Quality Operations teams for investigations, change management, and batch record review, and establish effective CAPA plans.
- Leadership: Participate in and/or lead QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards.
- Strategic Planning: Develop and/or contribute metrics to support product and/or process review efforts as needed.
- Department Goals: Develop department goals and objectives for senior management review in alignment with Acadia strategic planning.
- Other Duties: Perform other duties as assigned or required.
Requirements:
- Education: A Ph.D., Master's, or Bachelor's degree in Chemistry/Biology/Pharmacy or a related life science is required.
- Experience: A minimum of 8 years of related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry is required.
- Skills:
- Quality Assurance: Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and Swissmedic/EMA/MHRA and other international GMP regulations as they relate to clinical trials, product development, commercial requirements, and technology transfer.
- cGMP Regulations: Demonstrated proficiency in interpretations of cGMP regulations for Swissmedic/EMA/MHRA and other international regulations.
- Quality Management Systems: Experience implementing and managing quality management systems is an advantage.
- Supplier Audits: Experience conducting internal and supplier audits and manufacturing facility inspections is an advantage.
- Communication: Ability to interpret and relate Quality standards for implementation and review.
- Leadership: Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
- Teamwork: Able to gain cooperation of others.
- Global Experience: Experience in a global organization; ideally in the EU or Switzerland.
- Language: Fluent in spoken and written English (additional European language(s) an advantage).
-
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 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
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...
-
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:...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Senior Quality Assurance Specialist
vor 4 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 Assurance and Regulatory Associate
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 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...
-
Associate Director, GCP Inspection Lead EMEA
vor 1 Monat
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob Title: Associate Director, GCP Inspection Lead EMEABeiGene is seeking an experienced Associate Director to lead our GCP Inspection team in EMEA. As a key member of our Quality Assurance department, you will be responsible for ensuring our clinical trials are conducted in accordance with regulatory requirements and industry standards.Key...
-
Associate Director, GCP Inspection Lead EMEA
vor 1 Monat
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob Title: Associate Director, GCP Inspection Lead EMEABeiGene is seeking an experienced Associate Director to lead our GCP Inspection team in EMEA. As a key member of our Quality Assurance department, you will be responsible for ensuring the compliance of our clinical trials with regulatory requirements.Key Responsibilities:Lead GCP inspections conducted by...
-
Associate Director, Product Quality Lead
vor 1 Monat
Basel, Basel-Stadt, Schweiz Moderna Therapeutics VollzeitAbout the RoleWe are seeking an experienced Associate Director, Product Quality Lead to join our Quality Assurance team in Basel, Switzerland. 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...
-
Associate Director, Product Quality Lead
vor 3 Wochen
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 in Basel, Switzerland. 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...
-
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...
-
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...
-
Global Regulatory Quality Assurance Associate
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitAn exciting opportunity has arisen for a highly motivated Quality Assurance and Regulatory Associate to join our ambitious forward-thinking team at Stratpharma AG in the centre of Basel. This role will work closely with our International QARA Director in managing the company's global QA and RA functions.As a highly successful company with an impressive 200%...
-
Associate Director
vor 3 Wochen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob Title: Associate Director - Risk ManagementBeiGene is seeking an experienced Associate Director to lead our Risk Management team. As a key member of our Clinical Development organization, you will be responsible for creating risk assessments, following up on quality signals, and contributing to the advancement of our Risk Based Quality Management (RBQM)...
