QC Compliance Manager

  • Location: Sellersville, Pennsylvania
  • Type: Direct Hire
  • Job #17923

QC Compliance Manager
Location: Near Sellersville, PA

The Quality IT Systems Lead oversees and directs Quality projects at the site level, serving as a liaison between site and corporate quality management (Information Systems). They resolve computer quality issues, promote communication, and improve site Quality IT/IS processes. 

Job Description
•    Review and approve regulatory computer system documentation.
•    Ensure consistent use of policies, procedures, standards, and guidelines.
•    Coordinate compliance audits and in-process audits.
•    Develop and maintain site repositories for computer validation and maintenance documentation.
•    Provide consultation and oversight for Quality IT and other computer system projects.
•    Assist in resource assessment, scheduling, and management of outside contractors.
•    Develop cost estimates and track schedules for Quality IS projects.
•    Define and ensure compliance with Site-specific IT system SOPs.
•    Define validation strategy and review validation deliverables for QC/Manufacturing systems.
•    Provide support for site-specific projects by the Corporate IT team.
•    Collaborate with Site DICO and IT SPOC for Data integrity compliance.
•    Investigate incidents/deviations and define RCA and CAPA accordingly.
•    Conduct trainings and awareness programs on CSV and IT Compliance.
•    Attend Governance meetings and ensure adherence to corporate standards.
•    Coordinate all Quality IT activities at the site.
•    Implement and manage site activities according to the Quality IT strategic plan.


  • B.S. in Chemistry or related science.
  • 3 years of laboratory experience.
  • Knowledge of quality practices, metrics development, project management, automated system validation, data integrity, and electronic records.
  • Familiarity with pharmaceutical automation systems is a plus.
  • Understanding of validation requirements for software and equipment.
  • Technical troubleshooting ability in a pharmaceutical environment.
  • Strong decision-making skills, resilience, and commitment to improvement.
  • Experience in training and supporting analysts.
  • Proficiency in MS Office

For more information or immediate consideration send resume to lisabarrett@scientificsearch.com, job#17923