Clinical Quality Specialist
SonderMindSalary not specified
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Experienced in GCP Quality Assurance
- Knowledge of ICH GCP and global regulatory requirements
- Ability to interpret and apply clinical and regulatory compliance requirements
- Experience with clinical trial documentation, study processes, and operational plans
- Ability to collaborate with clinical study teams and CROs/vendors
- Experience developing and executing GCP audit plans
- Ability to assess and manage risks associated with vendors
- Experience with data integrity and management
Responsibilities
- Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors
- Ensure clinical trials are conducted in accordance with GCP principles
- Evaluate clinical trial documentation, study processes, and operational plans
- Interpret and apply clinical and regulatory compliance requirements
- Collaborate with clinical study teams to provide vendor quality oversight
- Develop and execute GCP audit plans
- Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures
- Work with cross-functional teams to assess and manage risks
- Assist in periodic reporting of key quality metrics
- Promote a culture of quality
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this role remote or onsite?
This is an onsite role based in South San Francisco, CA.
What is the salary range for this position?
This information is not specified in the job description.
What key skills and experience are required for this role?
The role requires experience in GCP Quality Assurance, providing quality oversight and GCP guidance to clinical study teams and CROs/vendors, ensuring compliance with ICH GCP and regulatory requirements, and evaluating clinical trial documentation and processes.
What is the company culture like at Septerna?
Septerna embraces diversity of thought, expertise, and background through collaboration, cultivates an environment where employees succeed by learning from each other and working as a team, and shares a fearless pursuit of ground-breaking innovations.
What makes a strong candidate for this position?
A strong candidate is experienced, dynamic, results-driven, with expertise in GCP Quality Assurance, and able to provide strategic and operational quality oversight while collaborating with clinical teams in a fast-paced environment.
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
Related Jobs
RemoteRemoteDirector of Clinical Success
Abridge$260,000 - $300,000/year
Full Time
Expert & Leadership (9+ years)
RemoteClinical Review Quality Assurance Pharmacist
SmithRxSalary not specified
- Full Time
- Senior (5 to 8 years)
RemoteGCP Compliance and Process Lead, FSP
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
RemoteSenior Clinical Trial Manager / Associate Director
Abata TherapeuticsSalary not specified
- Full Time
- Mid-level (3 to 4 years), Senior (5 to 8 years)
RemoteDirector, Clinical Operations
AlmaSalary not specified
- Full Time
- Mid-level (3 to 4 years)