IT Quality Manager
The Company has adopted the 3 lines of defence model and the IT Senior Quality Management Director is primarily accountable for Line 1 Quality Management. This includes;
• Ensuring Compliance policies and standards are executed and adhered to across the company’s IT
• Ensuring Inspection Readiness for IT Systems at the company’s Campuses
• Day to day management of risk and controls
• Promoting strong culture of compliance and risk management
• Working in close partnership with operational managers who are responsible for implementing corrective actions and address process deficiencies
The Quality Management function is established to cover:
• Project Quality Management
• Service Quality Management
•Regional / Campus Quality Management
This function comprises Quality Management professionals that understand the company’s business processes and are experts at integrating business appropriate risk management techniques.
This function will also consult and educate business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.
The function is truly global in scale with resources in Asia, EU, North America and South America.
• The IT Quality Manager will facilitate the realization of the Quality Management strategy for specific areas in Quality Management.
• The role will be accountable for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet the company’s internal and external regulatory requirements.
• The role will act upon risks and issues in order to raise compliance and quality levels within IT and the business.
• Supports the development and roll out of training, education and awareness campaigns for quality and compliance.
• Contributes to the continuous improvement of IT Polices, standards and processes.
Candidate Focus & Challenge
• Demonstrated ability to lead the IT Compliance Quality input to System lifecycle activities in support of IT Delivery and maintenance.
• Collaborate closely with the project and service teams, ensuring an understanding of the areas of potential Compliance impact that the system may have based on the business process and use.
• Demonstrated experience in validation of laboratory and business applications.
• Collaborates with system/business process owner to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the GxP applicability, business, technical, software category, and regulatory risks.
• Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on GMP impact, validation lifecycle requirements, and quality, and compliance requirements.
• Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
• Experience in validation of laboratory and business applications.
• Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
• Ensure that the project and service teams understand the Quality processes.
• Maintains expertise in validation/compliance and develops a greater understanding of quality systems.
• Collaborates with project teams on compliance/technical issues related to validation lifecycle efforts to achieve compliance with company policies and government regulations.
• Leads / Participates in the Supplier Assessment to ensure that IT Suppliers meet the company’s Regulatory requirements.
• Ensure that relevant business procedures are being adopted and utilized
• Authors/reviews/approves departmental Processes
• Independently reviews validation documentation for compliance with company policies and government regulations.
• Collaborate closely with the Business and IT teams, ensuring an understanding of the areas of GxP, Sox, Data Privacy impact based on the business process and use
• Assist with interfaces with the wider Business compliance groups and provide assurance that compliance is maintained during quality management activities.
• Provide input to QC dashboard.
• Identify and report QC risks and issues to project and service teams
• Contribute / lead the development and roll out of training, education and awareness campaigns for quality and compliance
• Act as a QC point of contact for any potential internal and/or regulatory inspection
Candidate Knowledge, Skills & Experience
• BA, BS in Computer or Life Sciences with 3-5 years of experience in the pharmaceutical industry regulatory requirements
• Understanding of global Pharmaceutical Regulations (FDA, Annex 11, Sarbanes Oxley, etc.)
• Knowledge of industry best practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management
• A working knowledge of governance of 3rd party relationships.
• It is expected that the candidate would come from a good solid IT background, with a specialist in Quality, Compliance including Sarbanes Oxley.
• Experience of contributing to implementation of the Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
• Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
• Strong communication, influencing and relationship building skills
• Strong change leadership and team working skills
The ability to travel both domestically and internationally.
The position is located at Södertälje in Sweden.
This recruitment is handled by Dfind IT. If you have questions about this position, contact Ercan Bahar Recruitment Consultant email@example.com 072-246 74 09
Welcome with your application as soon as possible and no later than 15th of December