Diverse Lynx
Position: GxP Compliance Test Lead
Location:
Raritan, NJ (Onsite) Job Type:
Long Term Contract
Overview We are seeking a highly skilled
GxP Compliance Test Lead
to oversee validation and testing of software, systems, and processes within a regulated life sciences environment. The ideal candidate will ensure all testing activities meet
FDA 21 CFR Part 11, GAMP 5, and GxP compliance standards , leading quality initiatives from planning through execution and documentation.
Responsibilities
Lead validation and testing efforts for GxP-regulated systems and applications.
Develop and execute
test strategies, protocols, and traceability matrices
in compliance with
CSV (Computer System Validation)
standards.
Ensure test documentation aligns with
FDA, EMA, and global regulatory guidelines .
Collaborate with QA, IT, and business stakeholders to ensure systems meet quality and compliance requirements.
Perform
risk assessments
and maintain deviation, CAPA, and audit logs.
Manage test teams, schedule execution cycles, and report status to leadership.
Support audits and inspections by providing validation evidence.
Drive continuous improvement in validation processes and compliance frameworks.
Required Skills and Qualifications
Bachelor’s or Master’s in Computer Science, Life Sciences, Engineering, or related field.
12+ years
of testing experience, including
5+ years in GxP/CSV environments .
Proven experience leading teams in
validation testing for pharmaceutical, biotech, or medical device systems .
Hands-on experience with
ALM tools
(Client ALM, Jira, Veeva Vault QMS, etc.).
Strong understanding of
GAMP 5, 21 CFR Part 11, Annex 11 , and
data integrity principles .
Excellent documentation, communication, and audit-readiness skills.
Experience with
SAP, LIMS, MES, or other validated enterprise systems
is a plus.
Nice-to-Have
Experience with
Agile validation frameworks .
Knowledge of
cloud-based validation (AWS, Azure, GxP Cloud) .
ISTQB or CSV-related certification.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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Raritan, NJ (Onsite) Job Type:
Long Term Contract
Overview We are seeking a highly skilled
GxP Compliance Test Lead
to oversee validation and testing of software, systems, and processes within a regulated life sciences environment. The ideal candidate will ensure all testing activities meet
FDA 21 CFR Part 11, GAMP 5, and GxP compliance standards , leading quality initiatives from planning through execution and documentation.
Responsibilities
Lead validation and testing efforts for GxP-regulated systems and applications.
Develop and execute
test strategies, protocols, and traceability matrices
in compliance with
CSV (Computer System Validation)
standards.
Ensure test documentation aligns with
FDA, EMA, and global regulatory guidelines .
Collaborate with QA, IT, and business stakeholders to ensure systems meet quality and compliance requirements.
Perform
risk assessments
and maintain deviation, CAPA, and audit logs.
Manage test teams, schedule execution cycles, and report status to leadership.
Support audits and inspections by providing validation evidence.
Drive continuous improvement in validation processes and compliance frameworks.
Required Skills and Qualifications
Bachelor’s or Master’s in Computer Science, Life Sciences, Engineering, or related field.
12+ years
of testing experience, including
5+ years in GxP/CSV environments .
Proven experience leading teams in
validation testing for pharmaceutical, biotech, or medical device systems .
Hands-on experience with
ALM tools
(Client ALM, Jira, Veeva Vault QMS, etc.).
Strong understanding of
GAMP 5, 21 CFR Part 11, Annex 11 , and
data integrity principles .
Excellent documentation, communication, and audit-readiness skills.
Experience with
SAP, LIMS, MES, or other validated enterprise systems
is a plus.
Nice-to-Have
Experience with
Agile validation frameworks .
Knowledge of
cloud-based validation (AWS, Azure, GxP Cloud) .
ISTQB or CSV-related certification.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
#J-18808-Ljbffr