GxP Project Manager

GxP Project Manager

Duration: - 12 Months+

Location: - Vacaville, CA / Onsite

Project Management:

Stakeholder Collaboration:

Work closely with business leaders, functional teams, and external vendors to define project scope, goals, and deliverables. Establish strong relationships with internal and external stakeholders, including regulatory bodies and suppliers in the CDMO space.

Regulatory Compliance & GxP Requirements:

Lead the Project with Good Manufacturing Practices (GxP) and other relevant industry regulations. Ensure that all project activities are conducted in adherence to regulatory requirements.

CDMO Experience:

Bring deep expertise in CDMO environments, including an understanding of outsourced manufacturing, development processes.

Risk Management & Issue Resolution:

Identify, analyze, and manage project risks, ensuring issues are resolved promptly. Monitor and report on project performance and proactively suggest improvements or adjustments to project plans.

Vendor and Supplier Management:

Manage relationships with third-party vendors and consultants, including CDMO partners, ensuring alignment with project timelines, budgets, and deliverables.

Required Qualifications:

Experience:

Proven experience in CDMO environments, particularly within the biopharmaceutical industry.

Demonstrated experience working within GxP-regulated environments, with a solid understanding of FDA, EMA, and other regulatory requirements.

Technical Skills:

Strong understanding of business processes in the biopharma and CDMO industries (e.g., manufacturing, supply chain, quality control, etc.).

Project Management Skills:

Strong problem-solving and critical thinking abilities, with experience managing complex, high-risk projects.

Familiarity with project management methodologies (Agile, Waterfall, etc.).

Educational Background:

Bachelor s degree in Computer Science, Information Technology, Business, or related field. Advanced degree (MBA, MS) is a plus.