Senior Manager, Quality Assurance Technical

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Senior Manager Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (e.g. batch records) leads investigations and root cause analyses for deviations corrective and preventive actions (CAPAs) manages change controls and ensures compliance with quality and CGMP regulations. This role also supports validation automation data integrity environmental reports and facility reports while collaborating with internal stakeholders and clients on clinical and GMP events.

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

Major Accountabilities:

Manages a team of quality specialists and sets the direction and priorities to ensure a successful execution of projects and tasks
Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectivenessSupports client and regulatory inspections and serves as the subject matter expert (SME) for Deviations Corrective and Preventive Actions (CAPAs) and Change Controls
Problem solves with the team and determines effective solutions and root causes
Evaluates direct reports performance and addresses gaps appropriately while partnering with HR as needed
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.)
Encourages a culture prioritizing continuous learning and development including coaching and mentoring to position the team for growth
Participates in the recruitment process and retention strategies to attract and retain talent as needed
Performs other duties as assigned

Knowledge Skills or Abilities:

Effective communication both written and oral
Ability to lead teams projects and programs while effectively allocating resources
Ability to remain up to date on regulatory and quality requirements
Ability to effectively present information to others
Advanced knowledge of clinical and GMP manufacturing
Ability to continuously improve and utilize the PDCA method and create business processes
Ability to lead problem-solving sessions such as fish bone 8-step problem solving 5 Whys and FMEA

Minimum Education and Experience Requirements:

Masters degree in quality business management or other related field with 7 years of related experience; or
Bachelors degree in quality business management or other related field with 9 years of related experience
2-5 years of people management and leadership experience
Prior experience working in a CDMO

Preferred Education and Experience Requirements:

5 years of people management and leadership experience

Preferred Training or Certification Requirements:

Root Cause Analysis training
Problem-solving training

*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:

Senior Manager

Position OverviewThe Senior Manager Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (e.g. batch records) leads investigations and root cause ...