Atreca is an integrated biotechnology company located in South San Francisco, California (moving in 2021 to a new campus in San Carlos, CA). 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.
Reporting to the Director of IT, the Associate Director, GxP Applications will partner with business leaders to align IT GxP efforts with business requirements. Engage client leadership and IT to build out a robust and scalable GxP environment, ensuring that all technology, architecture, and governance are aligned to strategic business initiatives. This position will act as the IT GxP SME for all interactions with the FDA.
Duties and Responsibilities
- Build out GxP environment at Atreca using a strong understanding of business core functions and GxP compliance needs while considering short and long-term strategy
- Provides guidance and counsel on technology available that drives delivery of compliance solutions consistent with business direction
- Manage technology investments to align with IT compliance architecture and roadmap in partnership with the business.
- Collaborate with Legal and Compliance departments in development and implementation of compliance initiatives
- Lead / manage internal and external resources in support of business-related projects and activities.
- Collect and analyze business requirements, design, and document workflow of data between systems to enable an efficient, automated, and easily managed GxP environment
- Develop functional specifications to support systems and business process design that align with the IT Strategic plan
- Collaborate with business functions and technical team through the development and testing of solutions such as screen, interface, and GUI designs; ensure all approved requirements are met.
- Facilitate the evaluation and selection of new applications and functions and determine issues in services and software
- Represent IT during inspections and audits.
- Document GxP processes and procedures
- Champion system validation process
- Create SOP framework for regulatory compliance and computer systems validation
Required Skills and Qualifications
- Bachelor's degree in Business, Computer Science or Information Systems
- Master’s in Business is a plus.
- 15+ years of experience in IT, building and supporting enterprise applications required
- 10 years of experience in direct GxP related work in the Life Science industry including pharmaceutical, biotechnology or medical device required
- Strong business knowledge and ability to operate as the IT applications SME
- Knowledge and experience working within an SDLC framework
- Public company experience including working in a regulated SOX environment
- Ability to analyze and define business requirements and translate into technical solutions.
- Effective project management skills are essential; change management capability and desire to innovate and help lead change.
- Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills.
- Proven adaptability to shifting project schedules, priorities, and assignments; able to make effective decisions under pressure.
- Demonstrated problem-solver in a dynamic, fast-growing team environment.
- Experience with the following system types/platforms preferred: CTMS, eTMF, SAS, Data warehouse, BI, Safety, eQMS, EDMS and middleware
Special Skills / Knowledge:
- Strong written and oral communication skills
- Strong presentation and interpersonal skills
- Exceptional analytical, conceptual and problem-solving abilities
- Able to prioritize and execute tasks in a high-pressure environment
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Excellent organizational skills and the ability to balance several on-going projects simultaneously
- Ability to communicate ideas in both technical and user-friendly language.
- Experience working in a team-oriented, collaborative environment
- Working knowledge with CFR 21 Part 11, GxP Validated Systems, and Sarbanes-Oxley Regulations
- Experience in working with the FDA on audit requirements
- Experience administrating and working with Master Control QMS platform
Exact title commensurate with experience. Atreca is an equal opportunity employer.