San Carlos, CA, US
Who we are
Atreca is an integrated biotechnology company located in San Carlos, CA in the San Francisco Bay Area. We apply our proprietary drug discovery platform to profile clinically relevant, active B cell responses in patients receiving successful treatment and, in turn, develop a portfolio of antibody therapeutics against novel tumor targets with the potential to treat large patient populations. Atreca seeks talented, driven individuals who are dedicated to making a positive impact on human health and are motivated to become key members of a growing biotechnology company.
Position Summary
Atreca is seeking an experienced professional to run our Quality Assurance functions. You will be responsible for supporting all QA functions and managing third party resources when needed.
This position will be responsible for directly performing or managing all aspects of Quality Assurance including maintaining and improving the Quality System (QMS and the company’s GxP SOPs), auditing and qualifying third parties performing GxP activities on behalf of the company, reviewing and approving data and documentation supporting key activities (batch release, change controls), and partnering across the company with other functions to ensure success and compliance. This position reports directly to the VP of Regulatory Affairs. We are seeking an outstanding Quality Assurance professional who is looking to take their career to the next level.
Duties and Responsibilities
Build on and manage the Quality Management System, including MasterControl QMS
Review and approve batch records, change controls, and issue COAs
Manage SOPs and training records via QMS
Design and implement QA strategies for the development, registration, and lifecycle management of Atreca products, such as contract service provider qualification, routine and for cause audits, and reporting quality metrics
Perform or manage qualifying and re-qualifying contract service providers via audits
Interpret, plan, and communicate QA requirements to all functions
Execute QA plans to support clinical trials, product manufacturing, lot disposition and validation
Support regulatory submissions, including but not limited to IND, CTA, BLA, NDA, MAA
Develop and implement a communication plan to inform key stakeholders of quality metrics
Stay current with industry trends and regulatory expectations for Quality Systems
Develop and implement policies and processes to conform with US, EU, and ICH regulations and guidelines
Required Skills and Qualifications
M.S. or Ph.D. in a relevant life sciences field
Minimum of 6 years of experience in life sciences Quality Assurance
Proven track record for QA success, such as establishing ground-up Quality Systems and CSP oversight, in the U.S and abroad, GxP training, CMO oversight, addressing deviations, investigations and CAPA, and implementing quality metrics systems
Knowledge of biopharmaceutical manufacturing and operations
Experience with GMP, GLP and GCP audits
Strategic thinking with demonstrated leadership skills and a strong technical background
Ability to monitor, analyze and report on evolving worldwide regulatory and quality requirements
Extreme attention to detail
Excellent interpersonal skills
Excellent communication skills (verbal, written, presentation)
Exact title commensurate with experience. Atreca is an equal opportunity employer.