Director, QA Drug Substance Operations

Fujifilm•Holly Springs, NC

41d

About The Position

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.

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

Nice To Haves

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

Responsibilities

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