Project Manager (Compliance ,Validation, Tech Quality ) Healthcare

Required Knowledge, Skills and Abilities:
University level degree in business/IT technical/scientific area or comparable education/experience.
Good knowledge and experience with GxP regulated processes in the pharmaceutical industry, preferably Quality Assurance, Supply Chain, Manufacturing or HSE (Health, Safety & Environment).
Practical experience and know-how in CSV (Computerized System Validation) area. (Additional experience in the Information Management /ISRM area being an advantage).
2+ years of professional experience in a similar or related role.
3+ years of working experience in CSV IT Projects.
Experience with GxP / CSV / e-compliance requirements in an IT context.
Experience in reporting to and communicating with Project Managers, Project Teams and Project Stakeholders (with and without IT background, with and without in depth Risk Management background, with or without CSV background)
Fluency (written and spoken) in English
Good Technical Writing and GDP (Good Documentation Practice) skills as the PQM has to author major validation documents like Validation Plans, Reports and other documents

Responsibilities :
Establishment of defined quality management framework of the program, including defining quality practices for the program, required quality-driven templates and driving documentation of quality practices in SOPs (QM). Drive an efficient program quality framework, harmonizing the requirements from different frameworks and driving collaboration across workstreams.

Principle author of key quality-driven project deliverables in alignment with relevant compliance experts, as well as manage quality for the program:
Define the compliance governance process for IM Transcend program
Document the compliance methodology for IM Transcend program
Review and/or approve quality relevant deliverables (e.g., stage gate relevant content)
Monitor processes to ensure compliance with accepted framework, methodology, or quality standards (e.g., SDLC)
Manage validation projects/sub-projects
Coordinate quality documentation/deliverables
Coordinate testing and ensure that it is geared to ensure a robust deliverable
Ensure that testing is adequately documented to ensure reproducibility
Author major compliance and program quality documentation

Act as a Quality Consultant
Possess a high-level current knowledge of the regulatory compliance landscape and know whom to contact for deeper regulatory advice (e.g,. ICFR, ISRM, TQ, BQ, Data Privacy)
Provide guidance to project teams on current program standards and quality practices
Be an SDLC SME
Ensure that relevant SOPs are followed throughout the project
Cooperate closely with relevant compliance functions
Escalate critical CSV or ISRM compliance findings / risks to the appropriate channels

Align with the program manager
Participate in the successful and documented project handover to operations
Prepare and reply to project-related CSV or ISRM audits, assessments or inspections where applicable
Contribute to and/or facilitate stage gate / check point reviews

Manage compliant testing by
Authoring Test Strategy & Plans and Test Summary Reports where applicable
Reviewing and approving test specifications and test results for compliance
Reviewing and processing test deviations if applicable

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.