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FUJIFILM Biotechnologies · 1 day ago

Director, QA Drug Substance Operations

Holly Springs, NC

Full-time

Onsite

Director/Executive

9+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Director, QA Drug Substance Operations will oversee Quality Product and Validation teams, ensuring compliance with Good Manufacturing Practices (GMP) regulations and fostering a strong Quality Culture within the organization.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

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

Qualification

CGMP manufacturingQuality Assurance (QA)People managementQuality Risk ManagementTrackWiseVeevaSAPSyncadeOperational excellenceCollaborationTeam managementMentoring

Required

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

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

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)