Job Summary: We are seeking an experiencedCSV Project Manager to lead and manage critical computer system validation (CSV) projects, ensuring all activities are conducted in compliance with regulatory requirements and quality standards. The ideal candidate will be responsible for coordinating efforts across various teams, managing stakeholders, maintaining project plans, and ensuring timely execution of validation activities. This position requires a deep understanding of a QA system, as well as the ability to effectively resolve conflicts, facilitate communication, and drive projects to completion.

Key Responsibilities:

Stakeholder Management and Communication:

Set up and organize regular meetings with project stakeholders, ensuring alignment on project goals, timelines, and deliverables.
Track responses and follow up with stakeholders to ensure timely action and resolution of issues.

Project Planning and Execution:

Develop and maintain comprehensive project plans, ensuring clear timelines, resource allocation, and task assignments.
Identify key milestones and monitor progress against deadlines, proactively identifying risks and issues that may impact project timelines or quality.
Drive the project through all stages, from initial setup to final conclusion, ensuring all tasks are completed to specification.

Documentation Management:

Understand and manage the creation, review, and execution of key validation documentation, including validation protocols, reports, test scripts, and evidence.
Ensure that documentation is aligned with company QA system standards and regulatory requirements.
Identify and resolve any issues related to documentation, such as unclear passages, mismatched concepts, or content discrepancies, through effective communication and adjustments.

Issue Resolution and Negotiation:

Identify and address mismatches in validation approach, including differences in test evidence, and script writing
Lead discussions to find common ground and consensus on the validation approach, ensuring all parties are aligned and in agreement.
Re-write or revise documentation and expectations where necessary to resolve misunderstandings or improve clarity.

Quality Assurance and Compliance:

Ensure all project deliverables are reviewed for compliance with international and company's quality standards.
Review validation summary reports to verify completeness and accuracy, and ensure that all requirements are met before project closure.
Take appropriate steps to address any non-conformities or gaps in documentation or execution, escalating when necessary.

Project Completion and Finalization:

Drive the project to a timely conclusion, ensuring that all validation activities are completed, reviewed, and documented as required.
Ensure stakeholder buy-in and final approval of all deliverables, providing any necessary documentation or reports for project closure.
Identify lessons learned and suggest improvements for future projects.

Qualifications:

Bachelor's degree in Life Sciences, Engineering, or related field.
Minimum of 5 years of experience in CSV or related project management roles, with a focus on regulated environments (pharmaceutical, biotechnology, etc.).
Proven experience in managing cross-functional teams and negotiating with stakeholders to resolve conflicts and achieve project goals.
Exceptional communication skills, with the ability to convey technical information to non-technical stakeholders and facilitate consensus.
Strong problem-solving skills and attention to detail.
Ability to work independently, manage multiple priorities, and adapt to changing project needs.

Preferred Qualifications:

Certification in Project Management
Experience with validation documentation, such as test scripts, validation protocols, and validation summary reports.
Familiarity with regulatory standards such as FDA 21 CFR Part 11, EU GMP, or other relevant industry guidelines.

Working Conditions:

Full-time position, with occasional travel required to meet with stakeholders and support validation activities at various sites.
Remote work options available, with occasional on-site presence required depending on project needs.

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