Associate Director, QC Compliance

Position Overview

The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department, responsible for ensuring adherence to quality systems and regulatory standards. This position is dedicated to overseeing key QC processes, including the lifecycle management of QC SOPs, training curricula, change control, deviation management, and data integrity. This leader will drive compliance within the Quality Control function.

Company Overview

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 FDB and help create 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 FUJIFILM Diosynth Biotechnologies call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Job Description

Reports to                Head of Quality Control

Work Location         College Station, TX 

 

Primary Responsibilities:

Compliance with Quality Systems:

• Lead efforts to ensure that Quality Control processes are in full compliance with established quality systems and GMP regulations.
• Collaborate with the Quality Assurance team to align QC practices with overarching quality standards without duplicating roles in QA.

Quality Standards and Process Management:

• Oversee the lifecycle management of Quality Control Standard Operating Procedures (SOPs), ensuring they meet quality requirements and are consistently followed.
• Develop and maintain effective training programs to enhance QC staff competence in compliance with quality systems.

Training Coordination and Effectiveness:

• Organize and oversee training activities, ensuring all QC personnel are knowledgeable and proficient in QC procedures and regulations.
• Evaluate the effectiveness of training programs, making adjustments to optimize learning outcomes and compliance adherence.

Change Control Management:

• Manage change control activities related to QC methods, equipment, and processes to maintain continuous compliance.
• Ensure thorough documentation and implementation of changes to uphold product quality and regulatory standards.

Leadership:

• Manage and mentor a team of QC Compliance professionals, fostering a positive and collaborative work environment.

Deviation Management and Trending:

• Lead deviation investigations within QC, ensuring robust root cause analysis (RCA) and application of corrective and preventive actions (CAPA).
• Conduct trend analysis on deviations to identify areas for process improvement and enhance compliance.

GMP Documentation and Data Integrity:

• Ensure meticulous compliance with Good Documentation Practices (GDP) and data integrity throughout QC operations.
• Conduct holistic reviews of testing, batch records, and stability studies to identify trends and rectify discrepancies.

Data Trending and Analysis:

• Direct data trending and analysis efforts to provide valuable insights into QC performance, helping drive improvements in quality and stability.
• Collaborate with QC teams to implement data-backed improvements that support compliance and quality enhancement.
• All other duties as assigned.

 

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or other scientific discipline and 8+ years of experience in Quality Control/Quality Assurance within the pharmaceutical/biopharmaceutical industry, focused on compliance and quality systems.
• 5 years of leadership experience required.
• Experience with data integrity and compliance as related to quality control labs preferred.
• Advanced degree preferred.
• Strong understanding of GMP regulations and QC process m