Sr. Manager, Quality Compliance

Fujifilm

Posted on : 21-05-2025

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1 Vacancy

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Job Location

Morrisville, NC - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 21-05-2025

Job Description

Position Overview

The Senior Manager Quality Compliance is responsible for the daytoday activities of the Pharmaceutical Quality Systems (PQS) team regarding Inspection Readiness Site Internal Audits and Quality Management Review (QMR). This role focuses primarily on creating and maintaining the site internal audit plan and performing associated audits. Additionally the futurestate of this role is to also lead and develop a Quality Assurance (QA) compliance team.

Company Overview

At FUJIFILM Diosynth Biotechnologies U.S.A. were leading the charge in advancing tomorrows medicines. If you want to be a part of lifeimpacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Diosynth Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMPcompliant 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 crosssection 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

Creates and maintains site selfinspection plan and performs site selfinspections and regulatory inspections
Coordinates all preparation activities to support inspections including but not limited to audit execution timely observation follow up providing report responses on behalf of the site and internal follow up
Seeks continuous improvement opportunities learned from audits/inspections and the PQS process
Leads Inspection Readiness activities and effectively communicates the inspection and audit timelines
Acts as the site Business Process Owner (BPO) for Inspection Readiness and Audits
Participates in data gathering and generation for site and global QMR
Supports creation and maintenance of quality assurance policies for all quality subsystems including learning set up for PQS including global processes
Interfaces with Regulatory Affairs and BPOs to develop robust compliance processes implements quality system strategies facilitates continuous improvement of PQS and interprets and implements QA standards within PQS
Maintains professional working knowledge of relevant regulations documents and standards and identifies best practices within the company
Provides QA oversight and support of project deliverables in accordance with governing processes and procedures for PQS
Contributes to developing and maintaining QA documentation procedures and processes for company and site objectives and QA support of manufacturing operations in a Current Good Manufacturing Practice (CGMP) regulated facility
Participates in streamlining and efficiency improvement initiatives with other FDB sites
Leads continuous improvement projects related to systems processes and documentation while serving as the sites subject matter expert (SME)
Administers company policies such as time off shift work and inclement weather that directly impact employees
Coaches and mentors direct reports to ensure the team is positioned for growth
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 other duties as assigned

Knowledge and Skills

Collaborative attitude with the willingness to work with global colleagues and crossfunctional teams toward company and department goals
Excellent communication skills both written and oral
Attention to detail and commitment to maintaining quality standards
Strong knowledge of software QA methodologies tools and processes
Strong analytical and problemsolving skills
Indepth knowledge of biotech product regulatory requirements
Ability to effectively present information to others
Knowledge and application of CGMP compliance and other related regulations
Ability to coach lead and develop individual contributors
Must be flexible to support 24/7 manufacturing facility

Basic Requirement

Bachelors degree in Life Science or Engineering with 9 years of applicable industry experience; or
Masters degree in Life Science with 7 years of applicable industry experience; or
PhD in Life Science with 5 years of applicable industry experience
5 years of people management & leadership experience
3 years of experience in GMP QA or similar role

Preferred Requirements

Experience in Validation CGMP Manufacturing Operations and/or Quality oversight in an FDA regulated facility

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes

Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. X No Yes

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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Manager

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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Sr. Manager, Quality Compliance

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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