Associate Director IT Validation Lead
4 days ago
Dyne Therapeutics Inc is seeking an experienced Associate Director IT Validation Lead to lead 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.
Key Responsibilities:
- 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 regulations
- Oversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matrices
- Ensure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such as Quality, Regulatory, IT and Operations to ensure systems meet business needs and regulatory requirements
- Serve as the subject matter expert on IT Validation-providing guidance and training to protect teams and stakeholders
- Manage and mentor a team of validation engineers and specialists, ensuring best practices are followed
- Lead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actions
- Maintain 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 requirements
Requirements:
- A bachelor's degree in computer science, Information Technology, engineering or related field. Advanced degree preferred
- Minimum of seven years of experience in IT validation, including three years in a leadership role with GXP regulated environments
- In-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirements
- Experience with validation of cloud-based systems and platforms in AWS
- Proven ability to manage multiple validation projects in a fast-paced environment
- Strong leadership skills with experience in mentoring and developing high performing teams
- Excellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organization
- Experience in managing validation activities during internal and external audits
- Experience managing evidence Collection and dissemination for assessments and audits
- Excellent analytical and problem-solving skills
- Ability to thrive in a fast-paced and dynamic environment
- Outstanding vendor management skills
- Certification in quality or validation (e.g., ASQ, ISPE) a plus
-
Associate Director, IT Validation Lead
4 days ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob SummaryThe 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...
-
Associate Director, Data Management Lead
2 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeJob Title: Associate Director, Data ManagementUpstream Bio is seeking an experienced Associate Director, Data Management to lead our clinical data management activities. As a key member of our team, you will be responsible for overseeing clinical data management activities within clinical programs, exercising vendor oversight of clinical data deliverables,...
-
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Clinical Business OperationsCompany 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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are...
-
Associate Director of Analytical Development
4 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director of Analytical Development to join our team at GlaxoSmithKline. As a key member of our organization, you will be responsible for leading a team of analytical scientists and ensuring the development, manufacturing, release, and stability testing of drug substances and drug...
-
Associate Director of Analytical Development
4 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleGSK is seeking a highly skilled and experienced Associate Director of Analytical Development to join our team. As a key member of our organization, you will be responsible for leading a team of analytical scientists and ensuring the development, manufacturing, release, and stability testing of drug substances and drug products.Key...
-
Associate Director
4 weeks ago
Waltham, Massachusetts, United States GSK Full timeAbout the RoleGSK is seeking a highly skilled and experienced professional to lead our Diagnostics and Precision Medicine team. As Associate Director, you will be responsible for developing and implementing diagnostic strategies to support our clinical studies and product development.Key ResponsibilitiesDevelop and lead end-to-end diagnostic strategies to...
-
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Associate Director, Clinical Business OperationsJob Summary:The Associate Director, Clinical Business Operations will provide strategic leadership and oversight for clinical trial financial management, vendor outsourcing, and budget management. This role will work closely with cross-functional teams to ensure efficient and cost-effective execution...
-
Associate Director of Analytical Development
4 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director to lead our Analytical Development team. As a key member of our Strategic External Development organization, you will be responsible for developing, manufacturing, and characterizing drug substances and drug products.Key ResponsibilitiesLead a team of analytical scientists in...
-
Associate Director, IT Operations
1 week ago
Waltham, Massachusetts, United States Wolters Kluwer Full timeJob SummaryWe are seeking an experienced Associate Director, IT Operations to join our team at Wolters Kluwer. The successful candidate will be responsible for leading the IT Operations team and ensuring the smooth operation of our IT systems.Key ResponsibilitiesLead the IT Operations team and ensure the delivery of high-quality IT servicesDevelop and...
-
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryAt BioSpace, Inc., we are seeking a highly experienced Associate Director, Companion Diagnostics Strategy to join our Precision Medicine Companion Diagnostics team. This role will be responsible for developing and implementing global diagnostic strategies to enable and support the global development and commercialization of medically...
-
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly motivated and experienced professional to join our team as an Associate Director, Companion Diagnostics Strategy. In this role, you will be responsible for developing and implementing global diagnostic strategies to enable and support the global development and commercialization of medically differentiated therapies.Key...
-
Regulatory CMC Director
2 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeJob Title: Associate Director/Director, Regulatory CMCAt Upstream Bio, we are seeking an experienced Associate Director/Director, Regulatory CMC to lead our regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for our biopharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global...
-
Associate Director
1 month ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking an experienced Associate Director to lead our Diagnostics Precision Medicine team. As a key member of our organization, you will be responsible for developing and implementing diagnostic strategies to support our clinical studies.Key ResponsibilitiesDevelop and lead end-to-end diagnostic strategies to align with clinical...
-
Waltham, Massachusetts, United States GlaxoSmithKline Full timeJob Summary:As Associate Director, Precision Medicine Data Science Lead, you will be responsible for developing clinical biomarker analysis plans in collaboration with biomarker and diagnostic leads. You will conduct data analysis to summarize and interpret clinical trial data for Clinical Study Reports and regulatory submissions. This role will provide you...
-
Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Affairs CMCDyne Therapeutics Inc is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond...
-
Waltham, Massachusetts, United States Boston Dynamics Full timeJob SummaryWe are seeking a highly experienced Technical Lead and Manager to join our Verification, Validation, and Test (VV&T) team at Boston Dynamics. The ideal candidate will have a strong background in test engineering and leadership, with a proven track record of developing and implementing effective verification and validation strategies.Key...
-
Associate Director of College Counseling
2 weeks ago
Waltham, Massachusetts, United States AFBA Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Director of College Counseling to join our team. The successful candidate will be responsible for guiding students through the college search, application, and decision-making processes.Key ResponsibilitiesSupport students and families in navigating the college search and application...
-
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Chemistry Manufacturing and ControlThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
-
Associate Director, Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionOverview:At Alkermes, we are committed to developing medicines that address unmet patient needs. As an Associate Director of CMC Regulatory Affairs, you will play a critical role in supporting post-approval CMC changes and global Supply Chain and GMP activities for our marketed products.Key Responsibilities:Develop and lead regulatory CMC...
-
Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Associate Director, Regulatory Affairs CMCJob Summary:Dyne Therapeutics is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...