Sr. Director, Quality Control

Fujifilm•Morrisville, NC

1d•Onsite

About The Position

The Sr. Director, Quality Control provides strategic, technical, and operational leadership to the site Quality Control Laboratories. This role proactively leads implementation of GMP industry standard methodologies across the Quality Control Laboratories. The Sr. Director, Quality Control plays a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site. At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

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
Strong orientation for quality, compliance, business ethics and customer service.
Strong leadership, collaboration, team building, program management and organizational skills
Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders
High level of integrity and a drive for continuous improvement
Strong collaboration and team building skills
Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution
Excellent interpersonal, organizational, and written and oral communication skills
Mastery knowledge of document management and lifecycle, and quality systems and their interconnections
Mastery of GMP, regulations, and inspection/audit readiness
Ability to coach, lead, and develop individual contributors
Must be flexible to support 24/7 manufacturing facility
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Ability to discern audible cues.
Ability to sit for prolonged periods of time up to 60 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.

Nice To Haves

12+ years of experience working in a regulated GMP environment

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