Senior Engineer / Manager, Computer Systems Validation
Location: South San Francisco, CA
Position type: Full-Time, Regular
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.
- Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
- FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas. FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
We are seeking a motivated and ambitious individual to join our IT group. This position will be responsible for developing and managing efficient processes to ensure IT quality and regulatory compliance. This individual will manage FivePrime’s Computer Systems Validation program which includes implementing and improving upon standard operating procedures and policies to meet 21 CFR Part 11 and industry best practices; guide and train users inside and outside the department on the validation program; participate on project teams involving validated systems throughout the organization and working within IT to develop and implement validation guidelines and procedure for applications and infrastructure validation projects. We would expect this individual to have a passion for quality, data integrity, technology and innovation. This position reports to Vice President of Strategic Technology Operations.
- Collaborate with business stakeholders and suppliers to develop and maintain validated computer systems for regulatory compliance (GxP and SOX).
- Proactively identify future needs related to GxP systems and work with system owners in groups such as Regulatory, Drug Safety, Clinical Operations, QA, and Biostatistics to develop the project scope and timelines.
- Partner closely with Quality to develop and implement an assessment tool for evaluating 21 CFR Part 11 applicability and compliance for new and existing computerized systems.
- Establish and maintain a Validation Master Plan for computerized systems.
- Establish and maintain compliance policies and procedures for ensuring that computerized systems comply with all regulatory requirements throughout each system’s life cycle. Implement quality standards and systematic processes (e.g., incident management, CAPA, change management) for quality risk management of IT operations.
- Establish a testing strategy, develop test specifications validation protocols, and scripts and manage test execution, review and documentation for applicable systems.
- Establish necessary training, including compliance training, for all users of computerized systems and ensure appropriate training records are maintained.
- Establish and implement a periodic review process for computerized systems to verify ongoing compliance with regulatory requirements.
- Collaborate with IT and Finance business units to maintain SOX compliance for in-scope financial systems.
- Other projects as needed.
- Bachelor’s degree in Sciences, Information Systems or related discipline
- 8+ years of relevant work experience in biotech industry and 5+ years of direct experience with compliance and computer systems validation.
- Experience with GxP regulatory requirements including validation and 21 CFR 11 compliance of computer systems.
- Experience with GAMP 5, risk-based approach to compliant GxP computer systems.
- Familiarity with business processes in clinical, regulatory, manufacturing and supply chain operations.
- Familiarity with SOX compliance a plus
- Excellent written and interpersonal communication skills
- Think strategically; proven ability to influence and collaborate with business stakeholders effectively and in a positive manner
- Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
Please submit your resume.