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FUJIFILM Biotechnologies · 1 day ago

Sr. Director, Quality Control

Triangle, NC

Full-time

Onsite

Director/Executive

11+ years exp

FUJIFILM Biotechnologies is leading the charge in advancing tomorrow’s medicines. The Sr. Director, Quality Control provides strategic, technical, and operational leadership to the site Quality Control Laboratories, ensuring compliance with GMP standards and fostering a quality mindset across the organization.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Develops and implements the strategy and roadmap for Quality Control at the Morrisville site, with the overall Global Quality Strategy generated at a global collaboration

Builds, develops and leads the QC team with intention, providing clear priorities, feedback and career development opportunities in alignment with the department’s objectives

Leads the growth and expansion of the QC team at the site including regional accountabilities for intra-company testing to support the Holly Springs site and additional sites

Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives

Oversees all QC operations including, In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, the Environmental and Utility Monitoring program

Supports and participates in client visits, audits, and regulatory agency inspections

Ensures budgets, timelines, schedules and performance requirements are established and met

Assures all areas of responsibility conform to cGMP and other appropriate regulatory

Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clients

Assures that all areas of responsibility are cGMP compliant and audit-ready

Oversees the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of products

Manages technology transfers and method improvements needed to assure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratories

Administers company policies such as time off, shift work, and inclement weather that directly impact employees

Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)

Coaches and guides direct reports to foster professional development

Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution

Performs all other duties, as assigned

Qualification

GMP complianceQuality Control leadershipBiologics QC experienceRegulatory inspectionsTeam managementContinuous improvementCollaboration skillsProblem-solving skillsCommunication skills

Required

Bachelor's Degree in Chemistry, Biochemistry, Microbiology or related field with 15+ years of experience OR

Master of Science (M.Sc.) in a related discipline with 13+ years of experience OR

Ph.D. in Science with 11+ years of experience

12+ years of people management, leadership, and team management experience

Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy

Experience leading client site visits, audits, and regulatory inspections

Experience managing in a matrix organization and collaborating at a global level

Experience working in a regulated GMP environment

Preferred

12+ years of experience working in a regulated GMP environment

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)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)