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, investigate root causes, and propose effective solutions to ensure efficient operations and compliance with regulatory requirements.

• You have a mature understanding of the broader business context, including safety, finance, supply chain, HR systems and their interdependencies.

Preferred:

• You have experience with aseptic operations and/or experience with device assembly (including autoinjectors)

The expected salary range for this position based on the primary location for this position ofHillsboro, OR is $22,000 - $227,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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