Senior/Executive Director, Manufacturing - Assembly, Packaging, Warehouse (CVRM)

Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply.  From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world.  We make our medicines at 9 sites around the world and coordinates all aspects of production of Roche medicines in all disease areas and dosage forms

To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina.  The  new site will focus on  large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). 

The Opportunity:

As the Senior/Executive Director, Manufacturing you are initially accountable for the design, qualification and ramp-up of the green field high volume facility’s assembly, packaging, and warehouse operations, including strategic workforce planning, hiring the respective personnel, setting up the organization, all relevant processes and documents/documentation (e.g. SOPs and batch documentation). You are responsible for ensuring timely ramp-up including the project management activities, IT systems and  definition of the specifications and processes in compliance with GMP/Quality requirements. You will identify timeline risks or bottlenecks for the project timeline or future site operations and take appropriate actions. You will work closely with all the key areas to achieve ambitious goals in terms of on time, on cost and on scope delivery. 

Following go-live of the facility, you will transition into a routine operations/site leadership position and will extend into daily operation responsibilities. As the owner of all Assembly/Packaging systems and assets, you are accountable for the safe, accurate & efficient preparation, maintenance, calibration, functionality and reliability of all respective manufacturing areas, equipment, systems, and processes.  You will build and effectively execute the agenda for Assembly and Packaging operations to ensure reliable delivery for commercial products and new tech transfers. You will build and maintain strong partnerships with other Manufacturing units, Quality, MSAT, Facility, Engineering & SHE, ITOT, Material Management, People & Culture, Finance, Global Operations and other functional areas to assure site and department goals are achieved. 

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant).  You will transition to local full time on-site work once the site buildings are built and equipment delivered. (International) travel of up to 30% of the time is expected during the project phase.

• You will lead the assembly, pack, and warehouse part of the User Team during the facility start-up project, prepare and transform into routine operations

• You will drive timely project execution through strategic thinking, technical and entrepreneurial understanding combined with social intelligence. 

• You will foster a strong mindset for safety, quality and compliance

• You will take purposeful and impactful decisions

• You will demonstrate disciplinary and professional leadership promotion and deployment of personnel including the assurance of adequate initial and ongoing training

• You will carry out employee appraisal reviews incl. performance assessment and salary responsibility

• You will define goals with employees and evaluate the achievement of goals. Support the development of employees

Who you are:

• You hold a Bachelors degree in pharmaceutical,  life sciences, physical sciences, or engineering with (20+ years for Senior Director and 25+ years for Executive Director level of) significant  bio/pharmaceutical  experience, including cross functional group management and proven end to end Pharma business execution experience.

• You possess significant professional experience in steriles manufacturing, including cross-functional team management and leadership

• You have extensive professional experience with operations management in high-volume low cost device combination products or similar, and related documentation and processes knowledge

• You have strong project management skills, ideally experience wit