Senior Manager, Process and Compliance (Finished Goods)

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO is divided into 2 operational functions: Aseptic Operations (Component Prep, Compounding & Filling) & Finished Goods (Inspection & Packaging).  These two combine to produce millions of units of life-saving medicine every year to patients around the world.
 

Job Summary:

In this exciting role, you will be responsible for end-to-end process and systems management in the Finished Goods operational function and seek to optimize the effectiveness & efficiency of the organization.  As the leader of this team, you will set the conditions for new process implementation, process validation, tech transfer & launch activities, and execution of process improvement initiatives; while also driving Batch Record Review, root cause analysis & CAPA determination, owns & improves Quality documents, defines key performance indicators, and delivers business insights through data analytics & visualization.  

You will work in close partnership with the Finished Goods Asset Lead (responsible for maintenance & troubleshooting) and Process Unit Leads (responsible for front-line, operational execution) to drive day-to-day production activities.  This role will also provide leadership to a cross-functional team of operational, engineering & quality professionals to drive performance monitoring, continuous improvement, operational effectiveness, and ultimately enable the safe & reliable delivery of pharmaceutical products.  

• You will partner with the Head of Finished Goods to create a shared, streamlined, strategic vision for the team and broader stakeholders, with a clear sense of how it connects to the overall organization.  Makes decisions & influences (up, horizontally, down) to execute that vision, and accepts responsibility for the outcomes.

• You will provide leadership to a cross-functional team that enables process robustness, continuous improvement, and ultimately drives performance of the organization.

• You will coordinate, facilitate, and oversee problem solving efforts on manufacturing related failures and help drive accountability with implementation of identified corrective actions. Oversight and execution of robust RCA/structured problem solving initiatives.  Promote “Right First Time” and “Fix it Forever” culture.

• You will be responsible for management of functional KPIs and metrics management, data collection & analysis, business insights, and establishing/executing routine performance review.

• You will be accountable for management and oversight of operational deviations, CAPAs & change controls, as well as business processes surrounding technical changes, document updates, and complaints, acting as a key interface with the Quality function for each of these processes. 

• You will successfully manage health authority and internal inspections for commercial production and launch products 

• You will partner with network peers/colleagues to facilitate knowledge exchange, share best practices, and collaborate strategically on business initiatives and exchange of talent possibilities. 

Who you are:

• You have a BS/MS degree in Science or Engineering with 12+ years of deep, relevant bio/pharmaceutical manufacturing, quality, or engineering experience You have a deep understanding of pharmaceutical processing principles, regulations, and industry guidelines/benchmarks.  This includes knowledge of the equipment, processes, and materials involved in biologics processing.

• You have a demonstrated ability to work effectively in cross-functional and multi-disciplinary teams, and collaborate with colleagues across many different functional departments (Operations, Engineering, QA, Supply Chain, Safety, etc.) to enable collective progress across the organization. 

• You have exceptional communication skills to facilitate effective teamwork & engagement within the team, as well as influence across the site’s organization.

• You have experience in working in an FDA regulated bio/pharmaceutical environment, and a strong understanding of cGMP regulatory requirements related to manufacturing processes in the pharma industry. 

• You have strong analytical and problem-solving abilities to identify and resolve process-related issues. Be able to troubleshoot problems, i