QA CSA Manager

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, 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 suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

Responsible for achieving operational goals for the Computerized System Validation (CSV/CSA) and Computer Software Assurance (CSA), impacting multiple systems. Manages 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/CSA requirements are met. Leads 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):

• Interface with internal and external partners to identify existing or potential computer system validation issues and collaboratively pursue solutions; evaluate proposed new computerized systems, data center hosting, networks, cloud and/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

• Leads assigned projects and/or supports 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 validation policies, procedures, and plans, recommend changes as needed

• 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

• Provide compliance guidance to the IT function, business leaders, and stakeholders

• Maintain the controlled inventory of GxP computer systems, identify deficiencies in the validation status and prioritize remedial actions based on risk

• 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 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

• Provide QA and validation leadership for regulated computer systems and apply risk-based methodology to validation and qualification efforts in compliance with global regulatory requirements (21 CFR Part 11 and EU Annex 11 or equivalent international regulations)

• Design, implement, and govern overall readiness of CSV/CSA and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections

• Provide Quality review and approval of Deviations, CAPAs, Change Controls and other quality events

• Participate and support the external audit program for vendors related to regulated computer systems

• Partner with key business stakeholders and senior management in the development of the computer system validation corporate strategy, provide subject matter expertise and lead the corporate wide CSV/CSA program through quality management and quality oversight activities intended to ensure overall global regulatory adherence

• Ownership of all CSV/CSA related policies and procedures, ensuring they meet organization needs and remain aligned to global regulatory guidance

• Other duties as assigned

Requirements:

• BS/BA degree in computer science, scientific or related discipline and 6+ years of regulated industry experience in hosting/defending external audits and regulatory inspections OR

• Master’s degree in computer science, scientific or related discipline and 4+ years of related experience

• Advanced understanding of 21CFR820, 21CFR11, Annex 11, GAMP 5, HIPAA, etc

• Ability to effectively convey compliance requirements to appropriate internal partners

• Ability to influence, negotiate, and constructively challenge to achieve productive solutions

• Maintains knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems

• Detailed technical understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches

• A thorough understanding of drug development processes from discovery through development and post-marketing

• Advanced communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management

• Ability to manage competing demands in a fast-paced, dynamic environment where collaboration, communication, prioritization, and flexibility are key attributes for success

• Experience managing multiple projects, including partnerships with external partners, simultaneously from design through deployment

• Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional teams

• Experience in developing an organizational “culture of quality” and risk-based validation activities

• Experience drafting, reviewing, implementing and ensuring compliance with validation procedures that drive efficiency and foster a creative approach to solving business needs

• Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products

• 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

• Experience in the utilization of risk analysis tools such as FMEA, FTA, etc

• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

• Works to improve tools and processes within functional area

• Developing reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $117,300.00-$170,050.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.