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1+ months

Document Change Control and Training Manager

Kelly Services
Schaumburg, IL 60173
**Kelly Services is actively recruiting for a Direct Hire opportunity for a Document, Change Control and Training (DCCT) Manager (hug plus if you have Master Control experience) located in Schaumburg, Illinois.**


The Document Change Control and Training (DCCT) Manager will be responsible for leading the Document Control Staff, ensuring the successful implementation, use of and maintenance of Master Control across the site, maintaining and improving the Quality Management System to ensure its effectiveness and compliance with FDA requirements for pharmaceuticals and medical devices as well as applicable global regulations and standards. The DCCT Manager will work with project teams and process owners on technical issues, impact analysis, justifications and training plans for changes as well as the initiation, planning, execution and verification phases of to ensure compliant change management practices and Master Control use. The DCCT Manager will provide oversight, support and resources required to execute and maintain QMS documents, change control and document training. The position is accountable for staff performance, metrics and monitoring of training and change control timeliness, and resolution of discrepancies and compliance issues.


**Essential Job Function of the Document Change Control and Training (DCCT) Manager will include:**


+ Review and maintain Quality Management System documents and procedures to ensure regulatory requirements are defined, implemented, maintained and effective.

+ Initiate changes to documents, guide execution of change management activities, review and approve document and process changes as well as ensure appropriate training is completed and effectiveness of training is demonstrated and documented.

+ Plan, lead, organize, monitor and control Document Center staff members and their activities.

+ Improve and maintain the Master Control electronic document system.

+ Work with functional Managers/ Directors/ VPs to gather user needs, incorporate their input into functional solutions, deploy new modules, provide advanced training to support process owners toward becoming power users and subsystem administrators.

+ Apply industry best practices, regulatory compliance, Data Integrity and QMS experience to facilitate the development of effective, efficient and compliant change management packages, training plans and Master Control reports.

+ Develop reports and metrics, based on needs of end users, Management, Notified Bodies, and Regulatory Authorities, to enable efficient real time QMS reporting, tracking and timeliness.

+ Provide training, both departmentally and across the organization, as required to fully and effectively implement the Master Control and Quality System documents.

+ Support governmental, organizational, and customer audits as needed.

+ Maintain current knowledge on industry best practices and regulatory requirements, changes, enforcements regarding Quality Systems, Document Control, Change Management, Training and Personnel qualifications as well as Master Control capabilities by actively participating in forums, User Summits, Advisory Boards, training events, etc.

+ Function as Systems Administrator for the Master Control.

+ Develop and maintain system procedures, forms, user access, and super-users of the system.

+ Support system upgrades and revalidation activities as needed to maintain the system, train end users and ensure any issues or bugs are resolved in a timely and compliant manner.

+ Follow up on support issues proactively to provide timely updates and resolutions to end users.

+ Work with the Master Control vendor and site IT to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.

+ User administration, including creating, changing, and disabling user accounts per approved procedures.

+ Maintain and continuously improve the QMS to ensure compliance with applicable regulations and standards while maximizing organizational efficiency and effectiveness.


**Requirements of the Document Change Control and Training (DCCT) Manager includes:**


+ Minimum of a Bachelor Degree in a scientific discipline

+ Quality or Regulatory Certifications are preferred

+ Demonstrated capability in change management, training, leadership and project management skills.

+ 10 years experience in an FDA regulated pharmaceutical and medical device industry in a Quality System position.

+ 5 years of management experience leading a Quality Assurance Change Management function.

+ 3 years of experience with electronic data management systems.

+ In depth knowledge of Quality Management Systems structure, life cycle management and relevant regulations and standards (21 CFR 11/ 210/ 211/ 820; ISO 13485; ICH guidelines, FDA guidances, Risk Management principles and Health Canada regulatory requirements)

+ Energetic, self-motivated, organized leader who is accustomed to working in a deadline-focused, high-pressure environment with regulatory compliance core knowledge.

+ Familiarity with and previous experience working with Master Control, preferably in a System Administration capacity.

+ Preferred experience with FDA inspections, Health Canada and Notified Body inspections as well as compliance remediation.

+ Proficient in interpreting regulatory requirements, standards and applying these to SAI documents, change management processes, training, personnel qualifications, Quality System requirements, good documentation practices, sound critical thinking and record management.

+ Excellent communication skills, written and oral, to lead, market and promote Master Control within SAI and to all departments and demonstrating the importance of quality and compliance.

+ Technical analysis background - able to use ROI and other tools to establish value able to identify opportunities to streamline processes, procedures, forms.

+ Excellent leadership skills, management of personnel and cross-functional teams.

+ Skilled at developing training materials and conducting training across all levels and functions including executive management. Proficient at training other trainers.

+ Proven project management and time management skills.

+ Able to monitor, track and trend the document control, change management and training programs to ensure compliance and timeliness, effectiveness and drive performance improvements.

+ Proficient in Microsoft Word, Excel, PowerPoint, Teams and Outlook.

+ Understanding of 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems.

+ Understanding of industry requirements and regulatory compliance obligations of data integrity, including FDA Guidance for Industry on "Data Integrity and Compliance with cGMP.

+ Ability to communicate, interact and work effectively with people from diverse ethnic and educational backgrounds, as well as across all levels of the organization.

+ Ability to apply problem solving, troubleshooting and interpersonal skills to successfully address major QMS and systems issues as well as personnel issues/conflicts.

+ Ability to work well in a cross-functional team environment as well as an independent self-starter.

+ Ability to receive feedback and seek guidance when needed.

+ Ability to research and data-mine requirements, bench-mark best practices and ensure compliant solutions, changes and processes are maintained.

+ Ability to establish and manage to a departmental budget, and to seek opportunities to improve processes and be cost efficient while maintaining compliance.

+ Demonstrated ability to interact effectively with customers, external third parties, auditors.


**Physical Requirements/Work Environment**

May need to sit or stand as needed. May require walking primarily on a level surface for periods during the day. May involve the use of a variety of office equipment such as computers, telephones, copiers, etc. Keyboard usage and frequency can be moderate to extensive. Position will spend a significant amount of time sitting but have the ability to move around. Lifting is minimal and does not routinely exceed ten (10) pounds. There is minimal bending, stooping or twisting involved.


The performance of this position is in a typical office environment with regulated temperatures, good lighting and traditional office equipment. No special Personal Protective Equipment is required. May occasionally require exposure to the manufacturing environment where under certain areas require the use of Personal Protective Equipment such as hearing protection.


If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-28 Expires: 2021-09-23

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Document Change Control and Training Manager

Kelly Services
Schaumburg, IL 60173

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