Compliance Specialist
Duration: 6 Months
Location: New Brunswick, NJ

Comments: Prefer candidates with Veeva, Document Management System, QMS along with above Job Description expectation. Remote/Hybrid option may be considered on case by case basis but not guaranteed.

IT Quality Compliance Specialist/Analyst

Responsibilities:
* Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and requirements.
o Carries out functions of the GxP-ITQA as directed including but not limited to:
?? Review and approval of key computer system Validation Life Cycle (VLC) deliverables;
?? Review and approval of test scripts and defects associated with computer system validation;
?? Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;
?? Ensure adequate and timely regulatory compliance support.
* Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
* Provide backup support for the department as needed and perform other assignments as required.
* Support internal and external (regulatory) inspection activities related to validated systems.
* Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
* Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
* Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.

Qualifications:
* Experience in the BioTech/Pharmaceutical industry or similar regulated industry required;
* Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes;
o Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements;
o FDA 21 CFR 11, EU GMP Annex 11 and GAMP 5 standards;
o Data Integrity Guidance;
* In-depth understanding of industry-accepted software development and validation life cycle programs and related IT controls;
* Experience with relevant GxP systems such as quality management systems, document management systems, ERP, training/learning management systems, clinical and laboratory systems preferred;
* Understanding of quality risk-management concepts (ICH Q9) preferred;
* Understanding of ITIL Framework concepts (e.g., Incident, Problem, Change management processes)
* Understanding of Good Documentation Practices
* Project management practices and techniques;
* Experience with automated testing practices and tools preferred;
* Computer hardware, software including MS Office and MS Project;
* External and internal inspections support a plus;
* Excellent analytical, interpersonal, and communication skills, including written and verbal communication.

Education:
* Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.

Job Requirements:
Compliance Specialist
Duration: 6 Months
Location: New Brunswick, NJ

Comments: Prefer candidates with Veeva, Document Management System, QMS along with above Job Description expectation. Remote/Hybrid option may be considered on case by case basis but not guaranteed.

IT Quality Compliance Specialist/Analyst

Responsibilities:
• Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and requirements.
o Carries out functions of the GxP-ITQA as directed including but not limited to:
?? Review and approval of key computer system Validation Life Cycle (VLC) deliverables;
?? Review and approval of test scripts and defects associated with computer system validation;
?? Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;
?? Ensure adequate and timely regulatory compliance support.
• Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
• Provide backup support for the department as needed and perform other assignments as required.
• Support internal and external (regulatory) inspection activities related to validated systems.
• Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
• Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.

Qualifications:
• Experience in the BioTech/Pharmaceutical industry or similar regulated industry required;
• Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes;
o Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements;
o FDA 21 CFR 11, EU GMP Annex 11 and GAMP 5 standards;
o Data Integrity Guidance;
• In-depth understanding of industry-accepted software development and validation life cycle programs and related IT controls;
• Experience with relevant GxP systems such as quality management systems, document management systems, ERP, training/learning management systems, clinical and laboratory systems preferred;
• Understanding of quality risk-management concepts (ICH Q9) preferred;
• Understanding of ITIL Framework concepts (e.g., Incident, Problem, Change management processes)
• Understanding of Good Documentation Practices
• Project management practices and techniques;
• Experience with automated testing practices and tools preferred;
• Computer hardware, software including MS Office and MS Project;
• External and internal inspections support a plus;
• Excellent analytical, interpersonal, and communication skills, including written and verbal communication.

Education:
• Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience.