Senior Pharma Project Leader, GMP & Regulatory

We make it GmbH; Bern; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

CSL Behring AG in Bern seeks a seasoned project leader to scope, develop, procure, construct and qualify new equipment and facilities to meet production throughput需求. Lead multidisciplinary teams through the full project lifecycle to deliver capacity expansion, aligned with global and local strategies.

The role requires extensive experience in managing budgets, risk, and regulatory submissions, with strong knowledge of cGMPs and FDA-regulated facilities.

Qualifikationen

• Successful studies in Engineering, Business Administration or Life Sciences.
• 10 years of experience in managing capital projects in the pharmaceutical industry.
• Experience with Annex 1 and filling lines is desirable.
• Knowledge of cGMPs and FDA-regulated facility operations.
• Ability to manage high-level project budgets and cross-functional planning.

Aufgaben

• Scope, develop, procure, construct and qualify new equipment and facilities.
• Lead multi-disciplinary teams through project life cycle to deliver capacity expansion.
• Maintain integrated project plans and monitor milestones and budgets.
• Provide cGMP compliant processes and facilities for FDA/regulatory approval.
• Generate regular project reports for site management and global committees.

Kenntnisse

Project management

Cross-functional teamwork

Regulatory awareness

Problem solving

Ausbildung

Engineering/Bachelor's in Science or MBA

Tools

Power BI/Clarity

TrackWise

Veeva

Jobbeschreibung

CSL Behring AG in Bern seeks a seasoned project leader to scope, develop, procure, construct and qualify new equipment and facilities to meet production throughput需求. Lead multidisciplinary teams through the full project lifecycle to deliver capacity expansion, aligned with global and local strategies.

The role requires extensive experience in managing budgets, risk, and regulatory submissions, with strong knowledge of cGMPs and FDA-regulated facilities.