GxP Business Analyst/Project Manager

Eliassen Group; United States; Remote; Confidential; Full time

Job summary

A leading biotechnology client is seeking a GxP Business Analyst/Project Manager for a remote long-term contract role. The successful candidate will manage compliance projects, gather requirements, and coordinate teams to ensure alignment during the project lifecycle.

Benefits

Medical benefits

Dental benefits

Vision benefits

401k with company matching

Life insurance

Qualifications

• Experience with regulatory environments and submissions requirements.
• Expertise in gathering and documenting business requirements.
• Excellent communication skills for stakeholder interaction.

Responsibilities

• Lead cross-functional initiatives for GxP compliance.
• Gather and document detailed business requirements.
• Coordinate teams to ensure alignment throughout the project.

Skills

Regulatory compliance

Project Management

Communication

Business analysis

Job description

Description:

**Remote**

Our Biotechnology client is looking for a GxP Business Analyst/Project Manager to come on for a long-term contract. This person is needed to help “keep the lights on” with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe.Regulatory requirements are constantly evolving, and our client has to keep product documentation up to date in order to be in compliance and continue to do business in different countries

Rate: $65- $75 / hr on W2

We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Responsibilities:

• Lead cross-functional initiatives to ensure GxP compliance with regulatory and submission requirements in domestic and international markets.
• Gather, analyze, and document detailed business requirements from stakeholders to support the development and implementation of effective compliance solutions.
• Evaluate and improve existing business systems and processes, identifying gaps in compliance or efficiency and proposing optimized solutions.
• Develop and manage project plans, timelines, and deliverables to ensure timely and successful project execution within GxP-regulated environments.
• Coordinate cross-functional teams, ensuring alignment and collaboration between technical and business stakeholders throughout the project lifecycle.
• Facilitate clear and consistent communication across global teams, serving as the primary liaison between business units and technical teams.
• Translate business needs into technical specifications to guide development and validation efforts in compliance-focused initiatives.
• Monitor project risks and issues, escalating as needed and proactively driving resolution to keep projects on track.
• Promote a collaborative, self-directed team environment, encouraging ownership and accountability in achieving project objectives.
• Prepare and deliver status updates, reports, and presentations for stakeholders at all levels, ensuring transparency and informed decision-making.

Experience Requirements:

• Experience with regulatory environments and submissions requirements for compliance in different markets (including international)
• Expertise gathering and documenting business requirements such that they may be captured and translated into effective solutions
  • Analyze and evaluate business systems, processes, and requirements
• Project Management skills to help drive value in a timely manner
  • Coordinate with teammates to ensure successful implementation of solutions
• Self-Reliant Team Player
• Excellent communication skills:
  • Proven ability to interact with stakeholders up and down—and across—the enterprise.
  • Equally good at communicating w/ business partners and technical teammates
  • Facilitate effective communication between teams