Senior Manager, External Quality Business Processes And Strategic Projects
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OverviewIn 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 / Benefitsannual bonus
vacation days
parental leave
bereavement leave
caregiver leave
well-being reimbursement
ResponsabilitàEstablishs 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 fondamentaliUniversity/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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