Description:


ROLE PURPOSE

Manage the Validation and Regulatory requirements for Pharma clients in such a way their Project deliveries are met. Provide a high level of expertise and consultation to the Project Manager on Validation, Quality management and Project Deliverables.He/She would also be involved in BA activities as needed for the project success.

MAJOR ACCOUNTABILITIES

· Understand and adhere to the Client Regulations/Processes, SOP on Project Management, Change Management, Document Management and Quality Management; and, Computerized System Validation concept with regards to document management, and V Model Methodology.

· Support the Project Manager throughout the project delivery, with regards to aspects of project related risk, compliance and quality. 

· Responsible together with Project Manager for the delivery of all defined Quality Management documentation

· Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation

· Maintain the project risk register for all ongoing projects, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures to enhance PQM’s deliverables and competencies.

· Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements

· Applies required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.)

· Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.

· Oversee the validation of the ICE deliverables

· Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable

· Manage appropriateness of preparation and readiness of the project for hand over of the system/processes to the operational organization together with the project managers

· Perform the project tollgate/check point reviews and post implementation reviews with reporting to management



KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS

· Able to manage direct relations with stakeholders and project team members

· Proactive and result oriented

· Dynamic, motivated self starter with excellent communication skills in English

· Achievement of agreed targets in terms of quality and time

· Achievement of service levels corresponding to projects standards



JOB DIMENSION

· Manage the delivery of the QM project requirements

· Manage the QM standards, Compliance Requirements and Controls end-to-end

· Lead escalations and ensure remediation is prioritized and performed proactively

· Host/Support GXP Audits

· Location for this position is Germany.



EDUCATION / EXPERIENCE

· 12-15 years relevant work experience in IT/QM compliance

· 8 years’ experience in Computer System Validation

· Excellent English communication skills, both written and oral, additional languages would be a plus

· GxP, 21 CFR Part 11 MUST SOX, SOX IT, Data Privacy, IT Security knowledge would be a Plus

· System Development Life Cycle and GAMP Knowledge

· Knowledge in CoBIT, RiskIT, ITIL, ISO9000, PMBok, Six Sigma a Plus

· Able to manage direct relations with stakeholders and project team members

· PMP, CISA, ISO 9000 QMS certified etc. a Plus