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Senior eCompliance Manager

Remote:

Full Remote

Contract:

Freelance

Experience:

Senior (5-10 years)

Work from:

Czechia, European Union

Offer summary

Qualifications:

Masters degree in a relevant field, Minimum of 7 years in eCompliance, Expertise in QA eCompliance and CSV, Experience with GxP IT systems.

Key responsabilities:

Develop QA eCompliance Assessment document
Provide approvals for global CSV deliverables
Guide on GxP IT systems lifecycle documentation
Review and approve critical documentation
Collaborate with stakeholders for system integration

Scalanto

2 - 10 Employees

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Job description

What are we looking for:

A highly experienced Senior eCompliance Manager with a proven track record in eCompliance, particularly within the context of mergers and acquisitions. The ideal candidate will have deep expertise in QA eCompliance, Computerized Systems Validation (CSV), and GxP IT system lifecycle management.

Position Overview:

Role: Senior eCompliance Manager
Industry: Pharmaceutical/Healthcare
Employment Type: Contract
Duration: 10 months
Location: Remote
Start Date: 24-Feb-2025
Application Deadline: 30-Jan-2025
Work Authorization: Due to legal requirements, this role is open only to candidates legally allowed to work in the European Union.

Key Responsibilities:

Develop the QA eCompliance Assessment and Remediation document in accordance with project timelines and methodology requirements.
Provide approvals for global Computerized Systems Validation (CSV) deliverables and manage changes for global systems.
Offer expert guidance on GxP IT systems lifecycle documentation, ensuring adherence to GxP requirements.
Review and approve critical documentation, including Joint Transfer Plans, Data Migration Plans, Joint Transfer Reports, and Data Migration Reports.
Collaborate with project stakeholders to ensure seamless integration of the acquired companys systems into the Clients environment.

Experience and Background:

Masters degree in a relevant field.
Minimum of 7 years of experience in an eCompliance role, with significant experience in mergers and acquisitions.
Proficiency in creating and managing QA eCompliance documentation.
Strong background in global Computerized Systems Validation (CSV) and GxP IT systems lifecycle management.
Fluent in English, with excellent communication skills.

Differentiating Qualifications:

Prior experience with eCompliance projects in large-scale mergers and acquisitions.
Strong analytical and problem-solving skills to address complex integration challenges.
Familiarity with data migration and joint transfer processes in the pharmaceutical or healthcare industry.