Quality Compliance Specialist

QUALITY COMPLIANCE SPECIALIST NEW BRUNSWICK, NJ Hybrid - Requires Onsite presence 2-3 days per week. Required Skills:

• University Graduate - BA/BS Life-Sciences degree or diploma preferred.
• Master of Science with 3 years' experience or a Bachelor of Science with 5 years' experience or Diploma holders with commensurate experience in regulated industry (e.g., 10+ years).
• Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures.
• Minimum 3 years' experience in regulated industry required for all candidates.
• Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required.
• Excellent analytical, interpersonal and communication skills, including written and verbal communication.
• Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
• Strong sense of ethics, diplomacy, and discretion.
• Commitment to Quality.
• Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
• Able to work effectively with multicultural workforce.
• Excellent team player attitude.
• Ability to manage competing priorities.
• Travel Required (nature and frequency) - about 5-10 % travel to meet with stakeholders, attend professional meetings and seminars.
• Previous experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA preferred.
• Experience in industry accepted software development and validation life cycle programs and related IT controls.
• Previous experience in risk-based approach to computerized system validation a plus.
• Understanding of quality risk-management concepts (ICH Q9) preferred.

• Provide quality assurance oversight 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 the Client requirements.
• Carries out functions of the Global Quality (GQ) GxP-ITQA Quality and eCompliance tower as directed including but not limited to:
  • Review and approval of key computer system validation life cycle (VLC) deliverables.
  • Oversight of key software development life cycle (SDLC) processes such as problem, incident, change, release, deviations, periodic reviews, and such.
  • QA Review and approval of validation deliverables associated with various systems such as clinical study databases electronic Case Report Forms (eCRF) and Interactive Response Technologies (IRT), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, local laboratory systems such as FTIR or HPLC systems and others as required.
  • Ensure adequate and timely quality assurance / regulatory compliance support.
  • Report on key metrics across the tower.
  • Provide support during regulatory agency and third-party inspections.
  • Research new technologies, understand existing processes, and reference recognized standards and frameworks.
  • Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.
  • Identify opportunities for continuous improvement.
  • Adherence to the Client Core Behaviors.
• Attend GQ ITQA Compliance tower meetings.
• Attend GQ ITQA departmental meetings.
• Interface meetings with functional areas supported.
• Departmental meetings.
• Lead of the GQ ITQA eCompliance tower.
• Other members of GQ GxP-ITQA and department management.
• Staff from the GPS and R&D departments involved in GxP regulated operations.
• Information Technology staff at commensurate levels of the organizations including but not limited to:
  • Information Security.
  • Validation Services.
  • Service and Provider Quality Management.
  • Hosting Services.
  • Contracted Enterprise Service Providers.
• Management and staff of the associated quality departments.