Quality Compliance Specialist

Must have's:
1) quality assurance mindset for computer system validation
2) regulatory expertise to read and interpret global GXP regulations, as well data integrity expectations
3) expertise performing test scripts, trace metrics, RRA and other validation deliverables, review and approval as a QA
4) Ideal candidate would have prior experience of REMS, Veeva systems

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 BMS 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.