McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. The Sr. Manager, Enterprise Quality Engineering will provide enterprise-wide Quality support, develop practices and standards, ensure regulatory alignment, and drive continuous improvement in key Quality programs.
Responsibilities:
- Provides oversight and guidance on product storage strategies and climate control across McKesson Corporation business units
- Develops best practices and industry standards for climate control and other critical Quality Assurance programs
- Designs and delivers product storage education and training, providing SME expertise
- Leads continuous improvement efforts for climate control, product storage, temperature mapping & monitoring, alarm strategies, and investigations
- Coaches and mentors across McKesson to further climate control knowledge and expertise
- Supports and conducts audits, assessments, and inspections when needed
- Stay current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards from BOP, FDA, ISO, EMA, and any other applicable domestic and international regulation
- Fostering a strong Quality & Regulatory culture through collaboration, feedback, and capability building
- Accelerate digital transformation. Simplify what matters most; drive targeted simplification of business-critical processes
Requirements:
- 10+ years of Quality experience, including minimum of 5 years of pharmaceuticals, medical devices, distribution, wholesaler, or other FDA-regulated industries
- Experience working within an operation site environment such as manufacturing, distribution, or pharmacy leading key Quality pillars. Controlled product storage area, continuous climate monitoring, and investigation experience a must
- Minimum Bachelor's degree in science or engineering required for this position, MBA and/or certifications are a plus
- Strong compliance mindset and knowledge of climate control regulations, practices, and expectations coupled with proficiency in an implementation approach for diverse businesses across McKesson Corporation
- Demonstrated experience managing or supervising a team
- Digital mindset, ability to lead and support digital transformation
- Proven ability to operate effectively in a highly matrixed environment. Problem-solver with the ability to translate qualitative and quantitative information into actionable recommendations
- Instills trust, confidence, and respect among peers and stakeholders