Pharma Facility Transformation & Operations Lead

MSD; Durham (NC); In loco; USD 142.000 - 224.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical Insurance

Dental Insurance

Vision Insurance

Retirement 401(k)

Paid Holidays

Vacation

Sick Days

Descrizione del lavoro

MSD in Durham, North Carolina, USA, is seeking a Transformation and Business Support Lead to guide a portfolio of strategic projects within our Vaccine Manufacturing Facility. You will lead cross-functional teams across Quality, Operations, Technology, and Compliance to ensure on-time delivery of key milestones.

The role emphasizes building a strong business-support function, strengthening core processes, quality systems, change management and documentation, with accountability for project

Competenze

• Bachelor Degree in Engineering, Science or related field.
• Minimum 8 years of experience with strong preference for Manufacturing Operations, Technical Operations, Quality Operations, or Site Engineering Services with supervisory responsibility with exempt personnel.
• Proven track record in pharma/biotech facility engineering/process changes controls & projects, with experience in driving strategic changes.

Mansioni

• Reporting to the Director, Operations, the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug product facility change controls as well as other strategic initiatives, as requested
• Unite Quality, Operations, Technology Operations, Maintenance, Digital Manufacturing and other supporting functions behind a single integrated execution plan.
• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification. Review and approve project documents as necessary.
• Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Supports team safety, environmental, and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.
• Establish and lead a business support team focused on strengthening core operational processes, including quality systems, change management, process optimization, documentation, and overall operations effectiveness.

Conoscenze

Cross-Functional Leadership

Driving Continuous Improvement

Engineering Principle

Facilities Construction

Facility Engineering

GMP Operations

Influencing Skills

Master Batch Records

Mentoring Staff

Operations Management

People Leadership

Regulatory Inspections

Talent Strategy

Technical Problem-Solving

Technical Transfer

Formazione

Bachelor's degree in Engineering, Science or related field

Descrizione del lavoro

MSD in Durham, North Carolina, USA, is seeking a Transformation and Business Support Lead to guide a portfolio of strategic projects within our Vaccine Manufacturing Facility. You will lead cross-functional teams across Quality, Operations, Technology, and Compliance to ensure on-time delivery of key milestones.

The role emphasizes building a strong business-support function, strengthening core processes, quality systems, change management and documentation, with accountability for project