FUJIFILM Corporation
Director Pharmaceutical Quality Systems
FUJIFILM Corporation, Thousand Oaks, California, United States, 91362
Overview
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.
External US
Summary of Position:
The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.
Reports to:
Head of Quality
Location:
Thousand Oaks, CA
Major Activities & Responsibilities:
Manages the Quality Systems and Compliance functions including Deviation, CAPA, Change Control, Risk Management, Training, Document Management, Validation (equipment and CSV), Supplier Quality (material suppliers and service provides), Regulatory and Management programs.
Lead Quality Systems and Compliance; own strategy to support business requirements.
Drive GMP system and process continuous improvement initiatives.
Responsible for training of Quality Systems and Compliance team members. Ensure a robust and effective site training program.
Maintain policies, standards and procedures for the Quality Systems and Compliance functions.
Oversee development of metrics and Management Review.
Act as Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
Leads GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
Anticipates and resolves problems effectively.
Expert in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
Provides guidance in the subject of aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and aseptic process simulation studies.
Ability to perform in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
Supports other GXP assignments as required.
Education / Experience:
8+ years of team management experience
Master of Science (M.Sc.) or PhD with 10+ years of experience; or
Bachelor of Science (B.Sc.) with 13+ years of experience; or
Associate Degree with 16+ years of experience
Behavioral Competencies:
Advanced communication skills
Self-starter (advanced skill)
Advanced problem solving skills
Advanced critical / logical thinking / analysis skills
Advanced risk management skills
Advanced project management skills
Advanced time management skills
Advanced conflict resolution skills
Advanced teamwork and collaboration skills
Advanced negotiation skills
Advanced innovative thinking skills
Advanced decision making skills
Advanced people management/ development skills
Advanced strategic leadership skills
Customer service-oriented
Goal/ results oriented
Detail oriented
Technical Competencies:
Mastery knowledge of cGMP
Mastery knowledge of aseptic techniques
Mastery knowledge of biopharmaceutical operations
Mastery knowledge of quality systems
Working knowledge of computer applications
Mastery knowledge of GXP enterprise systems
Mastery knowledge of regulations and compliance
Masterly knowledge of creating and approving technical documentation
Advanced knowledge of process and method qualification
Working knowledge of process and method qualification
Mastery knowledge of managing process introduction tasks
Masterly knowledge of Building new business processes / strategies for improvement and implementation
Mastery knowledge of demonstrating the feasibility / ROI of business processes / strategies for improvement
Work Environment:
Work is generally performed in a manufacturing and office environment, with some laboratory and warehouse environment work.
Physical Requirements:
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.
Salary and Benefits:
$180,000 to $240,000, depending on experience
Medical, Dental and Vision
Life Insurance
401k
Paid Time Off
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
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 place. 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.
Job Locations
US-CA-Thousand Oaks
Posted Date
2 months ago
(10/9/2024 1:12 PM)
Requisition ID
2024-28112
Category
Quality Assurance
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.
External US
Summary of Position:
The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.
Reports to:
Head of Quality
Location:
Thousand Oaks, CA
Major Activities & Responsibilities:
Manages the Quality Systems and Compliance functions including Deviation, CAPA, Change Control, Risk Management, Training, Document Management, Validation (equipment and CSV), Supplier Quality (material suppliers and service provides), Regulatory and Management programs.
Lead Quality Systems and Compliance; own strategy to support business requirements.
Drive GMP system and process continuous improvement initiatives.
Responsible for training of Quality Systems and Compliance team members. Ensure a robust and effective site training program.
Maintain policies, standards and procedures for the Quality Systems and Compliance functions.
Oversee development of metrics and Management Review.
Act as Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
Leads GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
Anticipates and resolves problems effectively.
Expert in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
Provides guidance in the subject of aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and aseptic process simulation studies.
Ability to perform in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
Supports other GXP assignments as required.
Education / Experience:
8+ years of team management experience
Master of Science (M.Sc.) or PhD with 10+ years of experience; or
Bachelor of Science (B.Sc.) with 13+ years of experience; or
Associate Degree with 16+ years of experience
Behavioral Competencies:
Advanced communication skills
Self-starter (advanced skill)
Advanced problem solving skills
Advanced critical / logical thinking / analysis skills
Advanced risk management skills
Advanced project management skills
Advanced time management skills
Advanced conflict resolution skills
Advanced teamwork and collaboration skills
Advanced negotiation skills
Advanced innovative thinking skills
Advanced decision making skills
Advanced people management/ development skills
Advanced strategic leadership skills
Customer service-oriented
Goal/ results oriented
Detail oriented
Technical Competencies:
Mastery knowledge of cGMP
Mastery knowledge of aseptic techniques
Mastery knowledge of biopharmaceutical operations
Mastery knowledge of quality systems
Working knowledge of computer applications
Mastery knowledge of GXP enterprise systems
Mastery knowledge of regulations and compliance
Masterly knowledge of creating and approving technical documentation
Advanced knowledge of process and method qualification
Working knowledge of process and method qualification
Mastery knowledge of managing process introduction tasks
Masterly knowledge of Building new business processes / strategies for improvement and implementation
Mastery knowledge of demonstrating the feasibility / ROI of business processes / strategies for improvement
Work Environment:
Work is generally performed in a manufacturing and office environment, with some laboratory and warehouse environment work.
Physical Requirements:
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.
Salary and Benefits:
$180,000 to $240,000, depending on experience
Medical, Dental and Vision
Life Insurance
401k
Paid Time Off
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
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 place. 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.
Job Locations
US-CA-Thousand Oaks
Posted Date
2 months ago
(10/9/2024 1:12 PM)
Requisition ID
2024-28112
Category
Quality Assurance
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies