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Assoc. Dir. Global Documentation & Change Management

Hitachi Chemical Advanced Therapeutics Solutions, LLC

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Allendale, NJ
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Job Description

As posted by the hiring company

Job Overview:

 
Assoc. Dir., Global Documentation & Change Management

 

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.  We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.


The Associate Director, Global Documentation & Change Management will assist with the overall leadership and implementation of global Document Management and Control and the Change Control Management program designed to comply with applicable laws and regulations. This position has accountability for development and oversight of global quality documents, the structure of the program, and the design, implementation, and continuous improvement of electronic document management systems. This position also has responsibility for oversight of the regional Change Management system and accountability for the design, implementation, administration, and continuous improvement of the electronic change management system. 


Essential Functions and Responsibilities
     
Documentation System Management:

Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures. 

Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival. 

Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents.

Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning. 

Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and/or updated to include current regulatory strategy and are contemporaneous with industry standards.

Leads the development of reporting on quality standards implementation across all functions.

Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution.

Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule. 

Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system.

Manages the document change request system at the global and regional level and provides guidance at the site level. 

Provides support during internal and external audits, including Regulatory Health Authority inspections. 

Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.

 

Change System Management:

Serves as subject matter expert for the regional change control system and associated requirements.

Develops standards and guidelines for change control inputs and requirements needed to support change control requests.

Oversees and administers the Change Control Board for regional/global Change Control requests and provides guidance at the site level. 

Leads the electronic change management governance process and serves as administrator to the e-system.

Interfaces with IT as the Business Process Owner for the electronic change management system. Develops and prioritizes system enhancements and added functionality based on business need.

As needed, works with Quality Assurance and functional area representatives or responsible change owners to develop change management strategies.

Develops and provide reports on change management process and progress for global dashboard. 


Qualifications
    
BA/BS in the Life Sciences is required.   MS degree in Life Sciences a plus. 

Minimum 7-10 years’ experience in Document Management and Control and 3-5 years’ experience in Change Management in FDA-regulated, GxP-related Industry is required.

Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices a must. 

Demonstrated experience with implementation and management of electronic document management systems required. 

Working knowledge of electronic change management systems or e-QMS required.

Experience with writing and approving Standard Operating Procedures and Quality Standards.

Ability to drive Quality projects for continuous improvement.

Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required.  Knowledge of European and Japanese Health Authority requirements is a plus.

Ability to work independently with minimal supervision is required.

Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams. 


Competencies/Candidate Profile
     
Strong computer skills are required.

Excellent oral, written, and verbal communication skills are required.

Proven leader and strong negotiation and collaboration skills.


Supervisory Responsibility
     
This role may have direct reports. The role also functions as an individual contributor role in a heavily matrixed environment. When having direct reports, the role is responsible for interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.


Minimum Required Training
     
Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates.


Working Environment
    
This is an office-based position in the Allendale, NJ location.  Phone conferences outside of normal working hours is required to interact with global counterparts.  Travel is required at approximately 15%.  

 

Physical Requirements


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. 

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch.

This role is sedentary.  An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods of time.


Other Duties
     
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.


Monday-Friday, Day Shift