Compliance Specialist

Job Title: Compliance Specialist

Location: New Brunswick, NJ

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 Client requirements.

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 approve 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 with 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

Experience in the BioTech/Pharmaceutical industry or similar regulated industry is 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;

Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements.

FDA 21 CFR 11, EU GMP Annex 11, and GAMP 5 standards.

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, and clinical and laboratory systems preferred.

Please share your resumes at chaitanya@starkassociatesllc.com or contact: 848-277-1023

Understanding of quality risk-management concepts (ICH Q9) is preferred.