NavitsPartners is hiring: Pharma / CMC Business Analyst - BA24-16974 in Philadel

Job Title: CMC Business Analyst (IT)

Location: North Wales, PA 19454 (Remote acceptable, occasional on-site meetings preferred)
Duration: 12 Months

"Pharmaceutical or CMC experience is strongly preferred"

Position Overview

We are seeking experienced Technical Business Analysts to join our Chemistry, Manufacturing, and Controls (CMC) operations team. The successful candidates will play a key role in gathering, analyzing, and documenting business requirements for system implementations and dashboard enhancements. These positions will require collaboration with the CMC Operations team, IT stakeholders, and cross-functional departments to ensure technical solutions meet business needs.

Qualifications

• Education: Minimum Bachelor's degree required.
• Experience: 6–8 years in a similar role, with a strong preference for candidates with pharmaceutical or CMC experience.
• Technical Skills: Proficiency in MS Office Suite, Veeva Vault, Power BI, and dashboard development.
• Preferred Expertise: Experience with system implementation and change management.

Responsibilities

• Requirements Gathering:

  • Collaborate with stakeholders to gather, analyze, and document business requirements for system implementations and enhancements.
  • Develop comprehensive documentation, including Business Requirements Documents (BRDs), Functional Requirements Documents (FRDs), process flows, and use cases.

• Technical Analysis and Implementation:

  • Translate business requirements into technical specifications for IT teams.
  • Oversee the planning and execution of system startups, working closely with cross-functional teams such as Quality Assurance, Regulatory Affairs, and IT.

• Stakeholder Communication:

  • Facilitate meetings and workshops to clarify objectives and requirements.
  • Act as the primary point of contact for inquiries and ensure alignment among stakeholders.

• Testing and Validation:

  • Create and execute test plans, test cases, and User Acceptance Testing (UAT) scenarios.
  • Ensure IT solutions meet operational needs.

• Process Optimization:

  • Assess and recommend improvements for existing CMC processes and systems.
  • Identify opportunities to enhance efficiency and compliance.

• Data Management:

  • Collaborate with the Strategic Lead to define data requirements.
  • Drive data integrity efforts within CMC systems.

• General Responsibilities:

  • Successfully manage multiple initiatives simultaneously.
  • Independently define concepts and work under the direction of project managers.
  • Analyze trade-offs between usability and performance needs.
  • Serve as a liaison between business units, technology teams, and support teams.

Key Competencies

• Strong analytical skills with the ability to interpret business needs and translate them into actionable requirements.
• Excellent communication skills to facilitate cross-functional collaboration.
• Demonstrated ability to work independently and prioritize effectively.
• Proficiency in developing requirement specifications and documentation.