We are hiring a Quality assurance manager!
We are seeking an experienced Quality Assurance Manager to oversee all aspects of our QA operations, including GLP compliance, SOP management, and external site supervision.
Key Responsibilities:
Manage and maintain GLP compliance for in vivo studies
Oversee non-GLP studies to ensure adherence to GLP principles where applicable
Develop, implement, and maintain company-wide SOPs
Supervise QA activities for external collaborating sites
Lead and coordinate QA audits for internal and external operations
Guide preclinical studies towards successful IND submissions (both in-vivo and in-vitro)
Ensure compliance with OECD guidelines and GLP standards
Train staff on GLP requirements and quality assurance practices
Liaise with regulatory bodies and clients on quality-related matters
We are seeking an experienced Quality Assurance Manager to oversee all aspects of our QA operations, including GLP compliance, SOP management, and external site supervision.
Key Responsibilities:
Manage and maintain GLP compliance for in vivo studies
Oversee non-GLP studies to ensure adherence to GLP principles where applicable
Develop, implement, and maintain company-wide SOPs
Supervise QA activities for external collaborating sites
Lead and coordinate QA audits for internal and external operations
Guide preclinical studies towards successful IND submissions (both in-vivo and in-vitro)
Ensure compliance with OECD guidelines and GLP standards
Train staff on GLP requirements and quality assurance practices
Liaise with regulatory bodies and clients on quality-related matters
Requirements:
Master’s degree in Biology or related life science field (required)
Minimum 2 years of experience in the preclinical industry
Demonstrated experience leading GLP preclinical studies
In-depth knowledge of GLP regulations, OECD/ICH guidelines
Strong understanding of in vitro and in vivo preclinical study designs
Excellent project management and communication skills
Ability to work effectively with internal teams and external partners
Preferred Skills:
Familiarity with international regulatory requirements (FDA, EMA, etc.)
Knowledge of quality management systems and risk assessment methodologies
Good communication skills, multitasking and leadership
Master’s degree in Biology or related life science field (required)
Minimum 2 years of experience in the preclinical industry
Demonstrated experience leading GLP preclinical studies
In-depth knowledge of GLP regulations, OECD/ICH guidelines
Strong understanding of in vitro and in vivo preclinical study designs
Excellent project management and communication skills
Ability to work effectively with internal teams and external partners
Preferred Skills:
Familiarity with international regulatory requirements (FDA, EMA, etc.)
Knowledge of quality management systems and risk assessment methodologies
Good communication skills, multitasking and leadership
This position is open to all candidates.
