Job Summary:
The Senior Business Systems Analyst – Quality Systems is responsible for the analysis, design, implementation, and continuous improvement of regulated business systems supporting Quality operations within a biopharmaceutical environment. Operating as a senior individual contributor, this role serves as a key liaison between Quality, IT, and business stakeholders to ensure Quality Systems are compliant with global regulatory requirements (e.g., FDA, EMA, ICH), scalable, and aligned with business objectives.
The role demonstrates deep expertise in Quality processes and regulated systems, independently manages complex initiatives, and provides thought leadership on system optimization, validation strategy, and data integrity.
Job Responsibilities:
- Lead requirements gathering, process mapping, and gap analysis for Quality Systems (e.g., eQMS, CAPA, Deviations, Change Management, Audit Management).
- Translate business and regulatory requirements into clear functional and technical specifications.
- Partner with Quality and business operations to design compliant and efficient system solutions.
- Ensure systems comply with GxP, 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+).
- Support system validation activities, including validation planning, risk assessments, IQ/OQ/PQ, and change control.
- Act as a subject matter expert for Quality Systems during internal and external audits and inspections.
- Own or support system lifecycle activities including implementation, upgrades, enhancements, and decommissioning.
- Identify opportunities to streamline Quality processes through automation, standardization, and system integration.
- Evaluate vendor solutions and support system selection activities.
- Serve as a trusted advisor to Quality leadership on system capabilities and roadmap planning.
- Lead cross-functional workshops and working groups.
- Mentor junior analysts and contribute to best practices for business analysis and validation.
- Support data governance, reporting, and analytics for Quality metrics and KPIs.
- Manages complex, multi-region or multi-site Quality System initiatives.
- Operates with a high degree of autonomy and minimal supervision.
- Problems are typically non-routine, requiring judgment, regulatory knowledge, and stakeholder alignment.
Required Knowledge, Skills, & Abilities
- Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline.
- Advanced degree or relevant certifications (e.g., CBAP, PMP, CSV, ITIL) preferred.
- 6–10 years of experience in business systems analysis, with at least 4–6 years supporting GxP-regulated Quality Systems in the pharmaceutical or biotechnology industry.
- Proven experience with eQMS platforms (e.g., Veeva Vault QMS, TrackWise, MasterControl).
- Strong background in system validation and regulated Software Development Lifecycle methodologies.
- Deep understanding of biopharmaceutical Quality processes and regulatory expectations.
- Strong analytical, documentation, and problem-solving skills.
- Ability to communicate complex technical and regulatory concepts to non-technical stakeholders.
- Experience working in global, matrixed organizations.
Desired Knowledge, Skills, & Abilities
- Experience with EtQ
- Experience with Computer Software Assurance (CSA)
- Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.
