Quality IT Systems Lead


  • Data integrity
  • Metrics
  • Computerized system validation
  • Collaboration
  • Communication
  • Documentation
  • Pharmaceutics
  • Automation
  • Recovery
  • Design

Job Description

Piper Companies is currently looking for an experienced Quality IT Systems Lead in Sellersville, Pennsylvania (PA) to work for an innovative and growing global pharmaceutical company. The Quality IT Systems Lead will play a significant role as the liaison between the site and corporate quality management (Information Systems).

Responsibilities for the Quality IT Systems Lead include:

• Oversee and ensure consistent use of Policies, Procedures, Standards, Guidelines, etc. relating to computer system development, operation and maintenance.

• Review and approve (or ensure review and approval of) System Life Cycle documents, specifications (user, functional, and detailed design) and SOPs, as required

• Facilitate site-based compliance audits of documentation repositories. Conduct site-based in-process audits of the Piramal SOP's deliverables for projects.

• Help resolve site computer quality issues and promote communication at the site, serve as a site trainer, when required, seek ways to improve the site Quality IT/IS and computer automation work processes. They will support the implementation of the computer validation strategy at the site and supply them with information about lessons learned from the IT & Quality Corporate group to promote consistency.

Qualifications for the Quality IT Systems Lead include:

• A minimum of 7+ years' experience with experience in a GMP, pharma/contract manufacturing environment. 2+ years of leadership experience.

• Experience with supporting Quality team projects, including commercial and clinical batches.

• Must be able to translate the regulations (e.g. 21CFR Part 11) and regulatory terms and intent into language that is understandable and meaningful to the customer/system owner.

• Provide computer system project support.

• Assist in the assessment of required project resources and scheduling.

• Collaborate with Site DICO and IT SPOC for Data integrity compliance for IT systems Assist in developing cost estimates for site Quality IS projects, when required.

• Develop and track schedules for site Quality IS projects from inception through completion.

• Define Site specific SOPs for IT systems and ensure compliance there of - e.g. CSV, Periodic review, Audit trail review, Backup/restore, etc

• B.S in Chemistry or related science

• 3 plus years related laboratory experience

• Knowledge in the following areas: Quality practices and processes, metrics development, project management, automated system validation, data integrity, security, electronic records, and electronic signatures within a regulated environment. Automated systems (Pharmaceutical automation systems)

• Strong MS Office experience

Compensation for the Quality IT Systems Lead include:

• Salary Range is $110,000 plus - dependent upon experience.

• Comprehensive benefits package