Senior Quality Expert (QMS)

PURPOSE AND SCOPE:
The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT department.

This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and quality in IT operations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* Responsible for documentation management and archiving within the QMS framework.


* Conduct QMS administrative work, including maintaining records, tracking metrics, and facilitating audits.


* Design and implement DTI (Department of Information Technology) IT processes and controls, including IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems.


* Identify training needs for DTI IT personnel to execute assigned QMS functions effectively.


* Develop training matrices and packages to support the qualification of IT personnel in implementing QMS processes.


* Develop change management strategies, including PowerPoint decks, and communication plans to facilitate smooth transitions within the IT department.


* Collaborate with cross-functional teams to ensure alignment of QMS processes with departmental goals.


* Support continuous improvement initiatives by analyzing data and identifying areas for enhancement within the QMS.


* Participate in QMS audits and inspections, addressing findings and implementing corrective actions as necessary.


* Stay updated on industry standards and regulatory requirements related to quality management systems in IT.


* Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)


* Understanding the method for the management of IT departments providing GxP system support/management


* Responsible for compliance in alignment with the defined QMS processes


* Responsible for the continuous improvement of the QMS framework

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

EDUCATION:


* Bachelor's degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role

EXPERIENCE AND REQUIRED SKILLS:


* Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements


* 2+ years of professional experience working with or owning computer software validation/system coordination


* Additionally, minimum of 5 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred


* Experience of working in a company m...