BioSpace, Inc.
Associate Director, IT Validation
BioSpace, Inc., Waltham, Massachusetts, United States, 02254
Job Details
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Associate Director of IT validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments. This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems across the organization. The Associate Director, IT Validation works cross functionally with IT Security, Quality, Regulatory, and Operations teams to ensure the implementation and ongoing compliance of IT systems with FDA, EMA, SOX, and other global regulations.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include:Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulationsOversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matricesEnsure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such (e.g., Quality, Regulatory, IT and Operations) to ensure systems meet business needs and regulatory requirementsServe as the subject matter expert on IT Validation-providing guidance and training to protect teams and stakeholdersManage and mentor a team of validation engineers and specialists, ensuring best practices are followedLead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actionsMaintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives.Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies. Provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirementsEducation and Skills Requirements:
A bachelor's degree in computer science, Information Technology, engineering or related field. Advanced degree preferredMinimum of seven years of experience in IT validation, including three years in a leadership role with GXP regulated environmentsIn-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirementsExperience with validation of cloud-based systems and platforms in AWSProven ability to manage multiple validation projects in a fast-paced environmentStrong leadership skills with experience in mentoring and developing high performing teamsExcellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organizationExperience in managing validation activities during internal and external auditsExperience managing evidence Collection and dissemination for assessments and auditsExcellent analytical and problem-solving skillsAbility to thrive in a fast-paced and dynamic environmentOutstanding vendor management skillsCertification in quality or validation (e.g., ASQ, ISPE) a plus.
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The Associate Director of IT validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders-especially within GXP environments. This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems across the organization. The Associate Director, IT Validation works cross functionally with IT Security, Quality, Regulatory, and Operations teams to ensure the implementation and ongoing compliance of IT systems with FDA, EMA, SOX, and other global regulations.
This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include:Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulationsOversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matricesEnsure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such (e.g., Quality, Regulatory, IT and Operations) to ensure systems meet business needs and regulatory requirementsServe as the subject matter expert on IT Validation-providing guidance and training to protect teams and stakeholdersManage and mentor a team of validation engineers and specialists, ensuring best practices are followedLead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actionsMaintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives.Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies. Provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirementsEducation and Skills Requirements:
A bachelor's degree in computer science, Information Technology, engineering or related field. Advanced degree preferredMinimum of seven years of experience in IT validation, including three years in a leadership role with GXP regulated environmentsIn-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirementsExperience with validation of cloud-based systems and platforms in AWSProven ability to manage multiple validation projects in a fast-paced environmentStrong leadership skills with experience in mentoring and developing high performing teamsExcellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organizationExperience in managing validation activities during internal and external auditsExperience managing evidence Collection and dissemination for assessments and auditsExcellent analytical and problem-solving skillsAbility to thrive in a fast-paced and dynamic environmentOutstanding vendor management skillsCertification in quality or validation (e.g., ASQ, ISPE) a plus.
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.