Senior Manager, Digital Quality Management Systems, Business Analyst

📋 Description

• Act as the System Owner for designated Quality GxP digital systems (such as eQMS, QualityDocs, etc).

• Lead and oversee the entire lifecycle of system implementations and enhancements.

• Collect and convert complex business requirements into functional and technical specifications.

• Drive process mapping, continuous improvement, and digital transformation efforts within the Quality domain.

• Collaborate with cross-functional teams, including QA, IT, Regulatory, Clinical, and external vendors, to ensure systems align with business objectives.

• Build and sustain strong relationships with business process owners.

• Plan and conduct User Acceptance Testing (UAT), training, and change management activities for new system features or implementations.

• Oversee project scope, timelines, resources, budgets, and risk management.

• Ensure continuous system compliance with relevant GxP, FDA, EMA, and ISO standards.

• Prepare and present high-quality project updates, stakeholder communications, and system documentation.

• Manage the governance, configuration, and administration of digital quality tools such as Veeva QMS.

⛳️ Requirements

• A Bachelor’s degree along with 7+ years of experience in Life Sciences, Engineering, Information Systems, or a related field within a regulated life sciences environment is required.

• A Master’s degree and 5+ years of experience in Life Sciences, Engineering, Information Systems, or a related field within a regulated life sciences environment is preferred.

• Proficient in Microsoft Office, Smartsheet, Teams, and various project management tools (e.g., JIRA, MS Project).

• Over 7 years of related experience in Quality Systems, project management, and business analysis.

• Strong knowledge of GxP requirements, Quality System Regulations (QSR), and validation practices.

• Demonstrated experience in managing enterprise system implementations (e.g., Veeva Vault, SAP, etc.).

• Familiarity with business administration for Veeva QMS.

• Expertise in process modeling, requirements gathering, risk assessment, and stakeholder facilitation.

• Lean Six Sigma or Agile certification is preferred.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Discretionary equity awards

• Employee Stock Purchase Plan