Director, QA Drug Substance Operations

Director, QA Drug Substance Operations

Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations.

In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams.

As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

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 process performance and environmental monitoring to ensure continuous improvement.
• Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network
• Actively participates in cross-functional initiatives to align global quality strategies
• Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations
• Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments
• Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines
• Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management
• Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success
• Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies
• Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities
• Performs other duties, as assigned

Minimum Requirements :

Bachelor's degree in engineering, life sciences with 13+ years of related experience OR Master's degree in engineering, life sciences with 11+ years of related experience OR Ph.D. in engineering, life sciences with 9+ years of related experience 10+ years of people management, leadership, and team management experience Experience in cGMP manufacturing operations and / or Quality role in an FDA / EMA regulated facility. Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. Experience collaborating and interacting with a global team.

Training and / or familiarity with Quality Risk Management principles

Preferred Requirements :

10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility Experience in other GMP functions (manufacturing, MSAT, Engineering) Strong track record of driving operational excellence Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade

Physical and Work Environment Requirements :

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 120 minutes

Ability to sit for prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and / or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).