Computer System Validation Manager
San Diego, CA

Job Description

Who We Are:

At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

What We Do:

Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.

About the Role:The Computer System Validation Manager will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, whether on-premises or cloud-based, are validated or qualified in accordance with corporate quality standards.

This role is responsible for the delivery of the Computerized System Validation (CSV) strategy across the enterprise and, therefore, will manage the validation of new systems as well as changes to existing systems by working closely with IT and functional stakeholders to achieve a culture of continuous improvement along with ensuring CSV requirements are met.

The CSV Manager will oversee GxP impacting projects to ensure that all applicable regulatory, quality, security, data privacy, and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.

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Your Contributions (include, but are not limited to):

* Provide compliance guidance to the IT function, business leaders, and stakeholders.
* Develop and harmonize validation policies, procedures, and plans.
* Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of pharmaceuticals in alignment with applicable worldwide regulations and standards.
* Maintain the controlled inventory of GxP computer systems, identify deficiencies in the validation status and prioritize remedial actions based on risk.
* Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
* Review incidents for GxP impact. Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
* Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
* Manage formal testing of computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery.
* Oversee the qualification and maintenance of the qualified status of the data center hosting corporate computerized systems and the network, etc.
* Interface with internal and external partners to identify existing or potential computer system validation issues and collaboratively pursue solutions.
* Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment.
* Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the team and wider business.

Requirements:

* Minimum 10+ years regulated industry experience and regulatory understanding (21CFR820, 21CFR11, Annex 11, GAMP, HIPAA, etc.)
* Education equivalent to bachelor's degree in an appropriate discipline.
* Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
* Detailed technical understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches.
* Experience in the utilisation of risk analysis tools such as FMEA, FTA, etc.
* Experience in hosting/defending external audits and regulatory inspections.
* Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
* Expert at managing complexity and multiple work streams in changing circumstances.
* Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
* Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
* Reaches across the enterprise to solve problems.

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.