Zifo is hiring for a compliance Lead to work with one of our Life Science clients in Emeryville, CA
This is a contract role - open to independent contractors.
This role will require 3 days per week on-site at our client in Emeryville, CA
This role is not eligible for visa sponsorship - candidate must be a US citizen or hold a Green Card
This role will not qualify for any relocation assistance
Qualifications:
- Bachelors or Master's degree in biology, biomedical engineering, chemistry, or a related field
- More than 10 years of industry experience working within the Lifesciences industry working closely with System Validation / Quality Assurance, GxP regulations & IT compliance
- Working experience on SaaS Validation (e.g systems ELN/LIMS, Clinical trial and data management systems, Clinical submission systems)
- At least 8 years of experience working with IT Change Management, Software Development Life cycle (SDLC) Service Continuity Data Protection/Backup
- Skilled at System Access & Inventory Management, IT Incident, Non-Conformance, CAPA Management, IT Document Control, Training & Curriculum Management
- Functioned as the primary IT contact for all GxP compliance audits and inspections.
- Experienced in development of IT compliance training to ensure staff understand & adhere to IT policies, procedures, controls & tools to ensure a compliant & consistent IT control environment.
Responsibilities:
- Ensures IT operates in compliance to GxP regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.
- Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.
- Manages IT policy, process & control effectiveness & to ensure compliance objectives are demonstrably met for in scope IT systems, data & processes.
- Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure the following key activities are effectively & efficiently executed for IT systems:
- System Validation/Assurance, Periodic Review
- IT Change Management & SDLC
- Service Continuity & Data Protection/Backup
- System Access & Inventory Management
- IT Incident, Non-Conformance, CAPA Management
- IT Document Control, Training & Curriculum Management
- Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.
- Conducts risk assessments of key systems, accounts, & other in scope areas & activities to inform & ensure compliance.
- Directly manages and acts as the primary IT contact for all GxP compliance audits and inspections.
- Provides expert consulting across stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.
- Leads the development of IT compliance training to ensure staff understand & adhere to IT policies, procedures, controls & tools to ensure a compliant & consistent IT control environment.
- Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood.
Top Skills
What We Do
Did you know that the saying ‘Curiosity killed the cat’ actually ends with ‘but satisfaction brought it back’? We suspect that the shortened version is the doing of grown-ups suppressing the innately curious child inside them!
For us at Zifo, we take curiosity as unbounded - it is a celebrated value. Curiosity does wonderful things - drive exploration, accelerate learning, inspire better solutions, lead to innovation, drive conversations. We believe that the scientific community’s most important duty to the world is to stay curious. And this is what we do at Zifo.
We have a global presence of over 1000 employees spread across our offices in US, UK, France, Germany, Switzerland, Japan, China, Canada, Singapore & India.
We offer services in areas such as Scientific Informatics, Lab Informatics, Clinical Biometrics, Regulatory Compliance including Computer System Validation and Genome Informatics across 20+ countries. Our customers include 7 of the Top 10 global Bio-pharma companies.
We are listed as 'Technology Fast 50' by Deloitte for 9 consecutive years (2012-2020) and as one of the 'Best Places to Work' for the past five years.
We strive to stay curious, day in and day out. Asking the right questions, and listening to provide the right solutions.
Write to us at [email protected].
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