Manager - IT Business Systems Quality/R&D
Manager - IT Business Systems Quality/R&D
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:As a member of the Allakos team, you will be responsible for partnering with Quality, R&D and other Allakos functions to identify, design, implement and support business capabilities. You will also manage and support Computer System Validation (CSV) activities.
The successful candidate must be an experienced professional with software development life cycle understanding, strong project management fundamentals, business process analysis skills, and best practice software configuration knowledge.
This position will work closely with business partners/stakeholders to integrate technology and business processes into effective, efficient, and scalable solutions. The success of the position will be measured on IT project management delivery, fit of technology solutions to business capability needs, business partners/stakeholder feedback and IT support metrics. This position is based in Redwood City, CA and reports to the Senior Director – IT Business Systems.
- Assure that GxP compliance requirements are properly assessed, and that appropriate Computer Systems Validation is implemented for both new solutions and improvements to existing systems
- Partner with Quality to establish and maintain CSV and GxP compliance
- Partner with functional business leaders to understand their technology needs and ensure technology investments are scoped and prioritized properly to maximize the company’s technology investments.
- Review system requirements and prepares recommendations anticipating future application needs.
- Lead new system selection processes including requirement gathering, RFP development, and software vendor selection.
- Responsible for providing day-to-day support, system administration, availability and performance monitoring, and continuous improvement activities for systems in portfolio; in conjunction, develops standard operating procedures (SOP), trains personnel on use and manages upgrade.
- Establish and maintain positive relationships with business partners including co-workers and management.
- Execute agreed upon service levels (i.e., project schedules, system availability, & service quality).
- Develop and maintain IT Roadmaps in association with Business Partners/Stakeholders
- Conduct ongoing research into industry and technology trends.
- Keep stakeholders sufficiently informed on progress with initiatives or deliverables
Qualifications and Expertise:
- Bachelor’s degree in the field of computer science or information systems or related field required, or equivalent combination of education and experience required.
- 5+ years working on IT implementation/management
- Experience in Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of solutions with a focus on GxP compliance
- Experience with Veeva Vault (Quality Docs, QMS) preferred.
- Experience with Computer System Validation.
- Strong project management skills and execution record
- Detail-oriented, well organized, and able to assume responsibility for specific project deliverables with limited supervision.
- Ability to deliver results in a fast-paced, deadline-driven environment that requires the oversight of multiple tasks simultaneously.
- Ability to provide Level 1 support for the applications in the portfolio
- Ability to effectively manage service providers/vendors supporting business systems
- Strong interpersonal skills and a demonstrated ability to work effectively both independently as well as in a team environment.
- Good communication skills and an ability to interact with staff of all levels of the company.
- Detail-oriented; with strong analytical, organization, and problem-solving skills.
- Must have the ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.
- Strong customer service orientation and a high-level understanding of business processes related to pharmaceutical corporate activities.