Senior Manager, External Quality Business Processes and Strategic Projects
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Overview
In this role you drive improvement of external quality (EQ) business processes and lead strategic projects to ensure compliant, efficient execution. You will embed a Process Excellence/Lean culture within EQ and act as the SPOC for data integrity, governance, and cross-platform harmonization. You'll influence global standards, manage a project portfolio, and support regulatory submissions while enabling knowledge sharing and change management. This is a chance to shape quality systems in a multinational, matrixed environment and impact patient safety at scale.
Retribuzione / Benefits
- annual bonus
- vacation days
- parental leave
- bereavement leave
- caregiver leave
- well-being reimbursement
Responsabilità
- Establishs a Process Excellence/Lean culture within EQ using methodologies (Lean, Value Stream Mapping) to identify and deliver improvements
- Owns and executes Root Cause Problem Solving to investigate and resolve issues
- Facilitates complex investigations with advanced techniques (Kepner-Tregoe) and applies statistical analysis to data
- Acts as EQ Data Integrity/Governance SPOC: design and implement the data framework and drive gap remediation and continuous improvement
- Maintains a sustainable knowledge management framework across platforms including train-the-trainer on Data Integrity/Governance
- Acts as EQ SPOC and SME for TransCend and Batch Release Hub; supports standardization and S/4 HANA adoption
- Ensures cross-functional alignment and risk-based mitigation strategies; resources EQ asks appropriately
- Manages the P&O project portfolio and defines KPIs for platform metrics and QMR
Requisiti fondamentali
- University/Bachelor's degree in sciences required; Master's degree preferred
- 10+ years in Quality Assurance/Quality Control/Validation/Engineering in pharma
- Working knowledge of quality systems (Risk Management, CAPA, Change Control, Document Management, Management Review)
- Proven knowledge of Data Integrity regulations
- Experience in FDA/EMA GMP-regulated environment; ISO familiarity preferred
- Proven project management skills and process excellence experience; Six Sigma/Lean certification preferred or willingness to obtain
- Budget management experience preferred
- Strong communication, leadership, and cross-functional collaboration skills
- Ability to analyze complex problems, work under pressure, and deliver solutions
- Willingness to travel up to 10% (domestic and/or international)
- Leadership
- Strategic thinking
- Communication and presentation
- Process Excellence/Lean
- Kepner-Tregoe and statistical analysis
- Data Integrity governance
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