Senior Manager, Computer System Validation
The Senior Manager, Computer System Validation (CSV) is responsible for providing guidance on GxP system validation activities and ensuring computer systems follow applicable regulations and standards including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This role is also responsible for the development and maintenance of Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing. Duties include overseeing and executing the validation of new systems; evaluating and performing periodic reviews of existing validated computer systems to ensure / verify continued compliance with appropriate regulations and maintaining required change control procedures. The Senior Manager, CSV will develop design and test documentation including user requirements, risk assessments (RA), test plans, Installation Qualification, Operational Qualification and Performance Qualification (/IQ/OQ/PQ) tests and validation summary reports. Essential Duties and
Responsibilities:
Draft IT computerized system validation (CSV) policies and SOP's, obtaining guidance from Information Technology, QA and other applicable department leads Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to:
Validation Plans, Risk Assessments, Project Plans, User/Functional Requirement/Design/Configuration Specifications, Qualification Protocols, Final Report, Change Controls, Periodic Reviews Lead risk assessments to determine testing strategies and scope of effort related projects and changes Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes Manage and oversee vendors and consultants providing CSV services Represent IT and CSV in audits, investigations and discrepancy resolution Participates on cross-functional teams dedicated to process improvement, efficiency and optimization Participates on cross-functional teams aimed at defining best practices and improving process performance Foster teamwork and drive project/process improvements Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution Expected to participate in cross-functional projects or teams in support of mission
Qualifications:
Minimally 6
years' experience with CSV in a life sciences, biotech or pharmaceutical company required, including GAMP5/CSA and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity Good understanding of Computer Software Assurance, experience in implementing CSA is plus Knowledge of CSV requirements and procedures (IQ/OQ/PQ) for SaaS based solutions Knowledgeable of FDA, GxP, EMA and International related regulations and guidelines Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems) Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter Must have strong leadership, negotiation and presentation skills Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies Excellent organizational skills and attention to detail and accuracy Experience supporting health authority inspections related to GxP systems Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Draft IT computerized system validation (CSV) policies and SOP's, obtaining guidance from Information Technology, QA and other applicable department leads Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to:
Validation Plans, Risk Assessments, Project Plans, User/Functional Requirement/Design/Configuration Specifications, Qualification Protocols, Final Report, Change Controls, Periodic Reviews Lead risk assessments to determine testing strategies and scope of effort related projects and changes Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes Manage and oversee vendors and consultants providing CSV services Represent IT and CSV in audits, investigations and discrepancy resolution Participates on cross-functional teams dedicated to process improvement, efficiency and optimization Participates on cross-functional teams aimed at defining best practices and improving process performance Foster teamwork and drive project/process improvements Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution Expected to participate in cross-functional projects or teams in support of mission
Qualifications:
Minimally 6
years' experience with CSV in a life sciences, biotech or pharmaceutical company required, including GAMP5/CSA and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity Good understanding of Computer Software Assurance, experience in implementing CSA is plus Knowledge of CSV requirements and procedures (IQ/OQ/PQ) for SaaS based solutions Knowledgeable of FDA, GxP, EMA and International related regulations and guidelines Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems) Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter Must have strong leadership, negotiation and presentation skills Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies Excellent organizational skills and attention to detail and accuracy Experience supporting health authority inspections related to GxP systems Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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