
Quality Operations Manager
3 days ago
Job Description:
">Quality Technical Specialist
We are seeking a Quality Technical Specialist to join our team. The ideal candidate will have experience in quality management, technical writing, and data analysis.
- 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 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.
Required Skills and 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 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.
Benefits:
- Competitive salary and benefits package
- Ongoing training and development opportunities
- Collaborative and dynamic work environment
Core Competencies:
- Leadership in Quality Governance
- 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.
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