Key Responsibilities -
Management Review
- Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content.
- Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA).
- Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items.
Inspections and Compliance
- Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence.
- Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts.
- Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows.
Technical Writing and Data Analytics
- Lead authoring and workflow coordination for periodic quality trend reports and related documentation.
- Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards.
- Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards.
Preferred Qualifications
- Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles.
- Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.
- Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights.
- Familiarity with electronic quality systems (e. g. , Veeva, TrackWise, SAP-QM, LIMS) and documentation practices.
- Excellent verbal and written communication skills, including experience presenting to senior leaders.
- Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.
Core Competencies
- Leadership in Quality Governance (e. g. , Management Review)
- Inspection Readiness and Compliance Assurance
- Quality Data Visualization, Interpretation and Analytics
- Technical Document Drafting and Workflow Ownership
- Cross-Functional Stakeholder Engagement
- Continuous Improvement Mindset
Basic Qualifications and Experience:
- Master s degree with 5-9 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.
