Director, QA Drug Substance Operations

Position Overview

The Director, QA Drug Substance Operations oversees the Quality Product and Validation teams, as well as the batch review and release teams. This role ensures all released batches are manufactured and tested in compliance with Good Manufacturing Practices (GMP) regulations, including, but not limited to maintaining quality systems aligned with CGMP, GDP, and regulatory standards, and ensures product compliance through robust quality systems. This role fosters a strong Quality Culture within the Quality function and across supporting teams. As part of the site Quality leadership team, the Director, QA Drug Substance contributes to the cohesive implementation of quality systems across the Holly Springs, NC site, and ensures alignment with organizational goals and regulatory requirements.

 

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

Job Description

What You'll Do

 

• Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment• Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements• Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards • Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation• Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary• Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements• Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle• Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed• Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards• Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports• Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness• Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities• Acts as a key advocate for quality excellence across all levels of the organization• Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility• Oversees the preparation of trend reports for proce