CSV Project Manager - Pittsburgh

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:

1. 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.

Requirements

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.