Global Director of CSV at Jobot

Global Director of CSV - Fully Remote - Excellent Pay & Benefits - Contract-Hire-Hire

This Jobot Job is hosted by: Dallas Gillespie
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Salary: $170,000 - $215,000 per year

A bit about us:

Respected mid-sized global laboratory company with incredible benefits.

Why join us?

FULLY REMOTE position
Exceptional benefits

Job Details

Position Summary:
The Consulting Director of IT Quality, Risk, Validation and Change Management at our company is responsible for the strategy, planning and execution of the global Computer System's IT compliance and quality and change management process ensure compliance with GXP, CFR and industry best practice. Provides leadership to direct reports and other personnel who support global Computer Systems regulatory compliance. Interfaces with our company QA to help ensure all regulatory requirements related to IT system validation, testing and activation are met before system are put into production. Working with QA and the ePMO, ensure the development of comprehensive activation / staff education planning is in place to support system go lives. This position manages the process and staff to ensure system implementations are properly managed from a IT validation, testing, change control and documentation perspective to ensure IT compliance with GXP / CFG and other regulatory requirements.

Operates as the IT oversight at Drugscan to ensure IT testing and change management for those non-regulated systems align to industry best practice.

Coordinates all computer systems regulatory and compliance activities with global regulatory, change management, and quality leaders. Responsible for Computer Systems regulatory compliance and risk management. Manages the Computer Systems quality system and controlled documentation including all SOPs, (Standard Operation Procedures) policies, working instructions, computer validation, Corrective Action Preventative Action (CAPA) management and departmental training records. Oversee the Computer Systems component of the Change Management process for the company. Evaluates current systems, processes, and technology, and proposes and leads improvement projects.

Desired Attributes:

• Seven years of healthcare-related experience in IT Quality, IT validation, IT risk management and IT change management with substantial hands-on computer system / software life cycle validation experience, preferably with LIS/LIMS software and in an organization that operates under the regulations of the FDA (GXP) and MHRA regulations.
• Certified Software Quality Engineer (CSQE) preferred
• Demonstrated capability to select and execute optimal / risk-based IT validation methods and techniques for obtaining results consistent with business goals
• Experience in FDA regulated environment with demonstrated understanding of cGxP (cGMP, cGAMP, cGLP) standards and Risk based validation
• Experience in data privacy and security regulations (e.g. HIPAA and GDPR)
• Demonstrated expertise in all computer-related aspects of GxP, including 21 CRF Part 11
• Experience in reviewing computer system validation artifacts, including system and user requirements, system management plans. validation scripts and traceability matrix and design specifications
• Experience in writing and executing documentation for all aspects of the IT validation deliverables (IT related compliance/validation plans, test protocols, validation summary reports and compliance/validation reports)
• Expert knowledge and application of Computer System IT Validation), IT Change Control and SOP development
• Demonstrated success managing personnel and vendors
• Excellent oral and written communication skills
• Effective interpersonal and leadership skills
• Demonstrated ability to work with others in a team environment CCMP (Certified Change Management Professional)
• Computer System Validation certification

Key Responsibilities:

• Working with IT and QA leadership, develops, reviews, modified, secures approvals and implements all IT validation, IT risk management, IT Change management SOPs ensuring that they and associated QA policies comply with all regulatory requirements (GXP, CFR, HIPAA).
• Manages all IT organizational controls / structures related to computer system implementation / IT validation / Change management in alignment of GXP and computer Systems best practice guidelines

Ensures that the alignment of Computer System IT validation / change management expectation to organization risk. Working with IT and QA, ensure the development and completion of necessary IQ, OP, PQ and UAT testing are completed and approved to support required system activation and CM requirements.

• Work in conjunction with our company QA leadership to ensure the development of comprehensive validation plans.
• Operates as the IT oversight at Drugscan (our company Subsidiary) to ensure IT testing and change management for those non-regulated systems align to industry best practice.
• Provides Computer Systems IT quality assurance oversight across the end-to-end product lifecycle for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to GxPs, guidance documents, applicable industry accepted standards
• Review / approve all IT department Computer Systems SOPs , policies, working instructions, training records, validation protocols and other controlled documents related to the delivery of compliant IT validation, risk management, testing and change management
• Responsible for programs and initiatives used to monitor and measure the overall quality of IT services, systems and software (implementation / support / Change Management)
• Ensures that validation / change management tracking systems capture useful operational metrics for use in reducing defects, improving services and optimizing implementation process.
• Work collectively with our company QA to provide oversight of Computer Systems QA activities for projects involving GxP (Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice) relevant computer systems.
• Work closely with project team members across all relevant departments to incorporate appropriate elements of IT quality, IT CSV / audit compliance and sound change management into the system lifecycle.
• Provide management, guidance, documentation and oversight of IT validation activities.
• Review and approve computer system IT validation artifacts.
• Provide leadership and tactical direction and guidance for changes to regulated computer systems.

Support internal and external compliance audits, including those with commercial clients and regulatory bodies. Coordinate audit preparation and response with all impacted departments.

• Evaluate areas of risk in IT business processes at our company and Drugscan. This assessment will be ongoing throughout the year as more information is discovered, or regulatory bodies change requirements
• Work collectively with IT security staff (our company / RRH) to address identified IT security issues and to manage the over IT (our company / DS) risk registry

Develop a plan and coordinate the remediation of any audit or internal control findings identified by internal or external auditors. Work with both internal and external auditors to ensure remediation plan will satisfy all regulatory body

• Review new client and IT vendor contract requirements related to IT validation, risk management and change management to ensure alignment and communicated to the proper our company staff of concerns.
• Engage in contract negotiations with clients/vendors to ensure their expectations align with the organization's capabilities and regulatory requirements
• Keep up with GXP and other auditing regulatory bodies' changes to regulations and interpret new guidance and new accounting standards and how to apply them to the company.
• Perform ad hoc IT risk assessments and drive improvements

Escalate and communicate control deficiencies to systems and business owners as required
Drives Change Management/Communication process and tools
Hire, develop, train, and evaluate the performance of Computer Systems Compliance staff.
Performs other duties as assigned.

Other Considerations:

• Ability to train and mature staff
• Secure the adoption of new process across the organization
• Experience with both lab equipment software and computer systems validation
• Proven experience interacting and creating relationships with Quality Assurance and operations.
• Experience drafting SOP aligned with regulatory requirements and organization expectations.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
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