Director, Quality Engineering & Validation (CVRM)

Pharma Technical Operations (PT) 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 internal and external sites around the world and coordinate 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), PT will construct a new manufacturing site in the U.S. in Holly Springs, North Carolina. The  new site will focus on large volume low cost Drug Product manufacturing. 

The Opportunity:

As the Head of Qualification/Validation you are initially accountable for providing Quality oversight for the qualification strategy and operational execution of all qualification activities of the green field high volume facility’s  equipment, systems, facilities and utilities, including strategic workforce planning, hiring the respective personnel, setting up the organization, all relevant processes and documentation (e.g. SOPs). You are responsible for ensuring timely ramp-up to support the overall project timelines including the project management activities, IT systems and  definition of the specifications and processes in compliance with GMP/Quality requirements. Together with IT you will identify the appropriate level of automation and digitalization for your area of responsibility. 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 Quality site leadership position and will take on daily operational responsibilities. As the Quality owner of all Qualification/Validation related activities and assets, you are accountable for the safe, compliant, accurate & efficient execution of all required activities to ramp up the site, establish products and ensure smooth day-to-day operations to enable reliable delivery for commercial products and new tech transfers. You will build and maintain strong partnerships with the other departments on site within and beyond the Quality organisation to ensure site and department goals are achieved.  

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office located on the U.S. east coast, later at the construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 40% of the time is expected during the project phase.

• You will provide Quality oversight (at first directly and later through your team) for the Qualification/Validation part of the User Team during the facility start-up project, prepare and transition into routine operations whilst building a high performing team to support all relevant activities.

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

• 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. You will support the development of employees.

Who you are:

• You hold a Bachelors degree in pharmaceutical,  life sciences, physical sciences, or engineering with 10+ years of relevant bio/pharmaceutical  experience in GMP regulated environments in Quality, Manufacturing Science and Technology, or Manufacturing. 

• You possess significant professional experience in the areas of qualification and validation, 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 manage