Oxenham Group
IT Business Systems Analyst- R&D
Oxenham Group, Boston, Massachusetts, us, 02298
Business Systems Analyst
Position Summary:
The Business Systems Analyst will play a pivotal role in documenting and improving business processes while supporting GxP-compliant systems. This role involves collaborating with cross-functional teams to identify and implement solutions that align with business objectives, with a particular focus on quality management systems.
Key Responsibilities: Business Process Analysis and Documentation: Collaborate with stakeholders to document business processes and identify areas for improvement. Develop and manage business requirements to ensure alignment with strategic goals.
Computer System Validation (CSV): Serve as the IT representative in coordination with Quality Validation and business stakeholders to determine CSV requirements and impacts. Execute and manage CSV activities, including planning, implementation, validation, and ongoing maintenance. Create and maintain validation documentation such as impact assessments, validation plans, user requirements/specifications, UAT scripts, traceability matrices, and summary reports.
System Support and Troubleshooting: Support and maintain operational procedures and processes related to GxP systems. Identify and resolve operational and system-related issues in a timely manner.
Collaboration and Communication: Act as a liaison between IT and business teams to ensure effective communication and consensus building. Provide support and training to end-users as needed.
Skills, Knowledge & Abilities: Strong customer service orientation with a focus on quality and attention to detail. Demonstrated ability to work both independently and collaboratively in a cross-functional team environment. Effective problem-solving skills with the ability to prioritize and plan effectively. Exceptional communication and facilitation skills to drive clarity and decision-making. Adaptability and accountability in a dynamic work environment. Qualifications and Experience:
Proven experience in business process analysis, development, and mapping, including gap analysis. Familiarity with quality management systems, with experience in Veeva Vault QMS highly preferred. A minimum of 5 years of experience in a pharmaceutical, biotech, or medical device industry is required. Experience working within GxP-regulated environments, including change control, change management, and CSV. Hands-on experience collaborating with SaaS vendors and managing outsourced solutions. Preferred Skills:
Expertise in implementing and maintaining GxP-compliant systems. Familiarity with regulatory requirements and quality standards within life sciences industries. Ability to produce detailed, accurate documentation to support validation and compliance initiatives.
The Business Systems Analyst will play a pivotal role in documenting and improving business processes while supporting GxP-compliant systems. This role involves collaborating with cross-functional teams to identify and implement solutions that align with business objectives, with a particular focus on quality management systems.
Key Responsibilities: Business Process Analysis and Documentation: Collaborate with stakeholders to document business processes and identify areas for improvement. Develop and manage business requirements to ensure alignment with strategic goals.
Computer System Validation (CSV): Serve as the IT representative in coordination with Quality Validation and business stakeholders to determine CSV requirements and impacts. Execute and manage CSV activities, including planning, implementation, validation, and ongoing maintenance. Create and maintain validation documentation such as impact assessments, validation plans, user requirements/specifications, UAT scripts, traceability matrices, and summary reports.
System Support and Troubleshooting: Support and maintain operational procedures and processes related to GxP systems. Identify and resolve operational and system-related issues in a timely manner.
Collaboration and Communication: Act as a liaison between IT and business teams to ensure effective communication and consensus building. Provide support and training to end-users as needed.
Skills, Knowledge & Abilities: Strong customer service orientation with a focus on quality and attention to detail. Demonstrated ability to work both independently and collaboratively in a cross-functional team environment. Effective problem-solving skills with the ability to prioritize and plan effectively. Exceptional communication and facilitation skills to drive clarity and decision-making. Adaptability and accountability in a dynamic work environment. Qualifications and Experience:
Proven experience in business process analysis, development, and mapping, including gap analysis. Familiarity with quality management systems, with experience in Veeva Vault QMS highly preferred. A minimum of 5 years of experience in a pharmaceutical, biotech, or medical device industry is required. Experience working within GxP-regulated environments, including change control, change management, and CSV. Hands-on experience collaborating with SaaS vendors and managing outsourced solutions. Preferred Skills:
Expertise in implementing and maintaining GxP-compliant systems. Familiarity with regulatory requirements and quality standards within life sciences industries. Ability to produce detailed, accurate documentation to support validation and compliance initiatives.