We are currently recruiting for an exciting Biotech company in Ireland who are looking for a Senior CSQ Team Lead for a long-term assignment.
More information over the phone but our client are looking to move quickly on this one. If you have IT Quality (ITQ), Compuer System Quality Assurance, IT Quality Assurance, or IT Compliance experience and fit the JD below, please reach out!
1. Work with leader of Computer System Quality (CSQ) group and site leadership to hire qualified resources and establish CSQ Team.
2. Lead CSQ Team to implement global computer system quality system (CSQS), and be the site liaison with CSQS owner.
3. Lead CSQ Team to perform the responsibilities of CSQ representatives for the site, provide daily CSQ oversight and guidance, and ensure the implementation of CSQS in the site. Specific responsibilities include but are not limited to the following:
- Make contributions to the continuous improvement of CSQS by gathering and analyzing feedback from business areas, and sharing the feedback with CSQS owner and CSQ group?
- Work with site CSQ Team to establish and implement local computer system quality and compliance procedures
- Establish effective communication with responsible functional area(s) and other global functional areas such as Automation & Information Systems (AIS), Engineering (ENG), and Process & Engineering Validation (PEV), and provide quality oversight and service in the areas related to computer system validation (CSV) and IT compliance with regulatory requirements, CSQS, and industry best practice.
- Apply risk-based approaches in daily quality work, and ensure computer systems in responsible areas are validated prior to go-live, and stay in continuous validated status throughout the life cycle of the systems?
- Conduct daily CSQ operation tasks: review/approve CSV documents, ensure CSV is conducted properly, approve computer system incidents, deviations, and CAPAs, coordinate computer system access roster review and periodic review, and so on and so forth.
3. Lead CSQ Team to work with CSQ supplier management process owner to ensure computer system suppliers in the site are properly assessed/audited before being used, and managed throughout usage.
4?Lead CSQ Team to assist internal and external audits and regulatory inspections.
5?Lead CSQ Team and work with Global Quality Compliance (GQC) groups (Data Governance, Quality System, Audit and Quality Compliance) and site business functions to ensure global GQC policies and procedures are properly implemented in the site.
- Bachelor or above degree majored in IT or other fields but with good understanding of IT
- 12+ years of work experience, at least 10 of which must be in life science industry and in areas related to CSQ (computer system quality, computer system quality assurance, IT quality, IT Quality Assurance, software quality, etc.)
- Leadership experiences and demonstrated leadership skills
- Good understanding and experiences in computer system validation (CSV)
- Familiar with software development life cycle (SDLC)
- Familiar with quality requirements of all stages in SLDC
- Good communication skills, particularly cross-function communication
- Good balance between having team spirit and working independently
- Familiar with questions and challenges in audits and regulatory inspections
- Passion for computer system quality field
ADDITIONAL POSITION SPECIFIC DUTIES/INFO
- Certifications with regulatory agencies (FDA?EU?WHO, etc.) preferred
- Certifications with quality organizations preferred