Stoke Therapeutics, Inc.
Manager, Document Control
Stoke Therapeutics, Inc., Oklahoma City, Oklahoma, United States,
Position Purpose:
The Manager, Document Control will support the maintenance of Stoke’s electronic document management system to ensure compliance with US and international regulations, laws, and guidelines.
This person will be accountable for maintaining Stoke’s Electronic Document Management System (Veeva Vault Quality) and related processes for document management and retention. This individual will contribute to maturing and shaping Stoke’s EDMS to meet the various phases of clinical development. In this role this candidate may be required to support GMP training, IT changes and computer systems validation, internal audits, and inspections. The candidate shall have a demonstrated ability to translate strategy into action with excellent analytical skills and an ability to communicate complex issues clearly to a broad group of people. This individual should have experience in orchestrating plans to resolve issues and mitigate risks in a timely manner. The candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This person will report to the Director of Quality Systems and will interface closely with other cross-functional groups such as CMC, Regulatory CMC, Regulatory Operations, Regulatory Development, Clinical Operations, Clinical Development, IT and other functions within Quality.
The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working in a virtual environment. It is preferred that this person have prior experience supporting regulatory inspections. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.
Key Responsibilities:
As the system owner, responsible for managing and administering Stokes EDMS.
As the assigned QA document control representative, responsible for processing Stoke’s controlled documents.
Responsible for maintaining compliance per Stoke document retention policies.
Responsible for maintaining Stoke’s Document Control & Document Retention program including necessary procedures, records, manuals, and trend reports.
Lead EDMS changes and process improvements to increase efficiency, effectiveness, continuous improvement, and maintain compliance with evolving GMP regulations and business needs.
Collaborate with IT on system risk assessments for new system releases for Stoke’s EDMS and periodic system reviews.
Contribute to Change Controls for configuration changes to support system enhancements for Stoke’s EDMS.
Generate and monitor metrics, including tracking and trending document KPIs to identify gaps and propose corrective actions
Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance for document management and data integrity.
Support GxP regulatory inspections and audits, as necessary and assist in training/preparing Stoke GxP employees for regulatory inspections.
Support Stoke’s Quality / Regulatory intelligence process to ensure that regulations, standards, and industry best practices are implemented for document control, GxP computer system validation and lifecycle management, GDocP, data integrity, document retention and archival.
Other duties as assigned.
Required Skills & Experience:
BS/BA, MS in life sciences or chemistry with a 5+ years of experience in document management.
Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting requirements for computer system validation and maintaining an EDMS for GxP applications in a practical manner.
Ability to identify areas of improvement and implement practical solutions as it relates to document management utilizing an EDMS.
Experience supporting regulatory inspections (back-room document management).
Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions.
Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA.
This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position may require approximately 5% travel.
#J-18808-Ljbffr
The Manager, Document Control will support the maintenance of Stoke’s electronic document management system to ensure compliance with US and international regulations, laws, and guidelines.
This person will be accountable for maintaining Stoke’s Electronic Document Management System (Veeva Vault Quality) and related processes for document management and retention. This individual will contribute to maturing and shaping Stoke’s EDMS to meet the various phases of clinical development. In this role this candidate may be required to support GMP training, IT changes and computer systems validation, internal audits, and inspections. The candidate shall have a demonstrated ability to translate strategy into action with excellent analytical skills and an ability to communicate complex issues clearly to a broad group of people. This individual should have experience in orchestrating plans to resolve issues and mitigate risks in a timely manner. The candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This person will report to the Director of Quality Systems and will interface closely with other cross-functional groups such as CMC, Regulatory CMC, Regulatory Operations, Regulatory Development, Clinical Operations, Clinical Development, IT and other functions within Quality.
The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working in a virtual environment. It is preferred that this person have prior experience supporting regulatory inspections. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.
Key Responsibilities:
As the system owner, responsible for managing and administering Stokes EDMS.
As the assigned QA document control representative, responsible for processing Stoke’s controlled documents.
Responsible for maintaining compliance per Stoke document retention policies.
Responsible for maintaining Stoke’s Document Control & Document Retention program including necessary procedures, records, manuals, and trend reports.
Lead EDMS changes and process improvements to increase efficiency, effectiveness, continuous improvement, and maintain compliance with evolving GMP regulations and business needs.
Collaborate with IT on system risk assessments for new system releases for Stoke’s EDMS and periodic system reviews.
Contribute to Change Controls for configuration changes to support system enhancements for Stoke’s EDMS.
Generate and monitor metrics, including tracking and trending document KPIs to identify gaps and propose corrective actions
Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance for document management and data integrity.
Support GxP regulatory inspections and audits, as necessary and assist in training/preparing Stoke GxP employees for regulatory inspections.
Support Stoke’s Quality / Regulatory intelligence process to ensure that regulations, standards, and industry best practices are implemented for document control, GxP computer system validation and lifecycle management, GDocP, data integrity, document retention and archival.
Other duties as assigned.
Required Skills & Experience:
BS/BA, MS in life sciences or chemistry with a 5+ years of experience in document management.
Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting requirements for computer system validation and maintaining an EDMS for GxP applications in a practical manner.
Ability to identify areas of improvement and implement practical solutions as it relates to document management utilizing an EDMS.
Experience supporting regulatory inspections (back-room document management).
Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions.
Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA.
This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position may require approximately 5% travel.
#J-18808-Ljbffr