Sr. Director, Quality Control

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

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.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays 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 youll find a home here where your efforts directly improve patients lives. Together lets 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 70000 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: Description

What Youll Do:

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 departments 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

Minimum Requirements:

Bachelors Degree in Chemistry Biochemistry Microbiology or related field with 15 years of experience OR
Master of Science (.) 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 Qualifications:

12 years of experience working in a regulated GMP environment

Knowledge Skills or Abilities:

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

Working & Physical Conditions

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.

*#LI-onsite

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Exec

Position OverviewThe 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 Cont...