QA Manager: MasterControl System, Document Control and Training

Manager Master Control System, Document Control and Training, Corporate Quality Assurance



Location: Boston, MA



Reporting to: Director, Corporate Quality Assurance



Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created.



This role will report to the Director, Corporate Quality Assurance located in Boston, MA and will be responsible for effective installation/configuration, operation and maintenance of the Orchard MasterControl Electronic Document Management System (EDMS),Learning Management Software (LMS), and Quality Management System (QMS).



The candidate will work closely with the software provider to resolve system issues, propose enhancements, deploy updates and test and implement additional functionality within the system.



This role will also be responsible for company document control including training to assure regulatory compliance.



RESPONSIBILITIES



* Develop and maintain installation and configuration management procedures.

* Contribute to and maintain system standards.

* Follow-up on support issues proactively to provide timely updates and resolutions to end



* users.

* Work with vendor to troubleshoot and resolve application issues.

* Coordinate and communicate with impacted stakeholders as needed.

* Work with the IT and validations teams to apply application version upgrades in a timely manner.

* Configure/add new services as needed.

* User administrator, including creating, changing and disabling user accounts per approved procedures.

* Work with existing process owners to deploy new modules, providing advanced training to support process owners becoming module power users.

* Work to develop reports, based on needs of end users and management, to enable efficient real-time reporting.



* Manages document and record workflows within MasterControl



* Ensures documents sent for approval conform to Orchard policy and SOP

* Ensures proper archival of GxP documentation

* As required, scan, index and upload documents and records in to MasterControl

* Assist in training and support of MasterControl end users

* Assist in the maintenance of electronic and/or hard-copy archives for applicable GxP.



* Oversees external distribution of controlled documents.

* Maintenance of Orchard SOP Training Program.

* Responsible for creation and effective delivery of training to Orchard Therapeutics.

* Works closely with Orchard Subject Matter Experts to understand and assess specific training needs.

* Communicates training needs to training management.

* Responsible for effective organization and delivery of GxP and other regulatory training, as required.

* Delivers initial and ongoing training for new hires and transfers.

* Facilitates transition of new hires/transfer-ins from training environment to work environment.

* Facilitates the assignment and un-assignment of training courses/modules for staff members.

* Prepares training metrics for Management Review.



Requirements



* Bachelors degree or equivalent education and work experience.

* Professional with a minimum of 5 years of experience with system administration in pharma, biopharma/biotech, or healthcare environment.

* Experience in Document Control, Training, and Archival

* Previous MasterControl experience required, preferably in a system administrator capacity.

* Experience with FDA 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems and data integrity requirements.

* Understanding of databases and data structures.

* Understand roles and security required when developing or customizing new solutions.

* Must have proficient computer skills in Microsoft Word, Excel and Outlook.

* Excellent problem-solving skills.

* Ability to read, analyze, and interpret general procedures, or governmental regulations.

* Ability to write reports, business correspondence, and procedure manuals.

* Demonstrated ability to interact effectively with company stakeholders at all organizational levels.

* Proficiency in both written and verbal communication and presentations.

* Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment.



* Demonstrated capability in solution deployment and project management is a plus.



RECRUITERS



All employment offers and CVs are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.