Regional QSE Director overseeing quality and food safety systems across the CCAR region. Partnering with stakeholders to drive compliance and continuous improvement initiatives.
About the role
- Senior Director-Molecule Steward Lead overseeing innovative biopharmaceutical programs. Managing a talented team and driving quality, robustness, and productivity across the product lifecycle.
Responsibilities
- Lead a group of Molecule Stewards (5-15) with end to end technical accountability for innovative programs
- Provide strategic Technical leadership to ensure successful new product introduction, launch, and improvements across the product lifecycle
- Develop and deliver the technical elements of the GSC strategy for long-acting injectable products with the GSC Strategic Lead
- Manage risk by ensuring alignment and consistency across supply nodes
- Coordinate the technical review of regulatory submissions and responses to technical questions across MSAT
- Representing MSAT as a single point accountable decision maker for GSC strategic team, CMC team, for established and new products
- Manage stakeholders effectively and maintain strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D
Requirements
- Bachelors degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field
- Experience in biopharmaceutical development, or a related scientific area
- Experience supporting molecule program management across preclinical and/or clinical stages
- Experience working within cross‑functional, matrixed development teams
- Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA) in a pharmaceutical or biologics development environment
- Experience supporting technology transfer activities within a product development environment
- PHD or Masters degree is preferred
- Strong communication skills in English and experience presenting technical information to diverse audiences
- Experience using risk-based approaches and project management tools
- Knowledge of global regulatory pathways for clinical development
- Comfort working in matrixed and cross-cultural teams
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
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