<p>Title: Director, Electronic Systems Compliance & Validation</p> <p>Location: Remote</p> <p>Position Summary</p> <p>We are seeking a Director, Electronic Systems Compliance & Validation, who will report to the Executive Director, GRC and Cybersecurity. You will be responsible for executing and coordinating key GRC operational programs across IT systems, processes, and third-party vendors, while maintaining alignment with applicable regulatory requirements and internal governance standards. This role supports the implementation and maintenance of Company's IT GRC framework and roadmap, aligning with industry standards to uphold the integrity, security, and compliance of IT systems and data.</p> <p>Working cross-functionally across business units, the Director manages the Computer System Lifecycle Management (CSLM) program, including system validation activities, coordinates IT change management processes, and contributes to policy and SOP governance and third-party risk management (TPRM). The role provides operational ownership of GRC activities across regulated IT systems, cloud platforms, and technology vendors, ensuring effective change control and risk mitigation. The position reports to the Executive Director of GRC and Cybersecurity.</p> <p>Responsibilities</p> <p>Compliance</p> <ul> <li>Manages the IT Change Management process. Works with IT and responsible business areas to assess the impact of system changes and recommended additional activities through formal change control processes. Review and approve change control deliverables. </li><li>Works with business units (QA, Legal, others) to interpret regulatory requirements for electronic systems to ensure compliance with regulatory requirements including GxP, Annex 11, HIPPA, GDPR, and other privacy laws etc. </li><li>Evaluates the adequacy and effectiveness of the company's information systems policies and controls. </li><li>Supports implementation and maintenance of regulated electronic systems to ensure compliance with applicable regulations. </li><li>Coordinates and tracks corrective actions resulting from internal or external audits. </li></ul> <p>Validation</p> <ul> <li>With oversight responsibilities, works with QA, IT technical staff, responsible business areas, and external vendors to develop appropriate validation approaches for implementation of systems. Review and approve validation deliverables. </li><li>As member IT project teams, works with project teams to help author/review gap assessments, user requirements, functional and configuration specifications, traceability matrix, test scripts, validation plans, IQ, OQ, PQ and summary reports. </li><li>Represents the validation/testing of electronic systems during internal and external audits. </li></ul> <p>Governance</p> <ul> <li>Ensures implementation of corporate SOPs and policies related to GRC processes for electronic systems across relevant business areas. </li><li>Executes compliance activities for regulated systems (e.g., GxP, SOX, HIPAA), operating within established governance frameworks and internal controls. </li><li>Works with QA and business units to develop standard approaches to 21 CFR Part 11, Annex 11, computer system validation, and electronic system compliance. </li><li>Partners with QA and IT technical staff to ensure consistent application of the Company's Computer System Lifecycle Management (CSLM) processes. </li><li>Supports governance and lifecycle management activities for third-party systems and service vendors, ensuring validation, regulatory compliance, and appropriate audit readiness </li></ul> <p>Risk</p> <ul> <li>Leads risk and regulatory applicability assessments for new IT systems or service changes within regulated environments, evaluating potential risks and compliance requirements. </li><li>Develops and implements risk mitigation strategies in collaboration with Quality Assurance, IT, and business stakeholders to ensure ongoing adherence to regulatory standards and requirements. </li><li>Conducts third-party vendor risk assessments to mitigate IT and security risks, collaborating with stakeholders to ensure third-party practices align with organizational security standards. </li><li>Facilitates risk governance by embedding risk management practices into system lifecycle processes and compliance frameworks to support inspection readiness and audit compliance. </li></ul> <p>Other</p> <ul> <li>Assists in regulatory inspections. Represent application design, functionality and technical controls during regulatory audits if needed. </li><li>Authors technical documentation for regulated systems, including SOPs, validation documents, white papers, monthly reports, status reports, and user manuals, as required. </li><li>Other duties as assigned. </li></ul> <p>Qualifications</p> <ul> <li>BA/BS degree or equivalent required, advance degree is preferred. </li><li>7+ years' experience successfully managing the validation, change management, and compliance of electronics systems information systems in regulated environments </li><li>5 years' experience successfully managing information systems in regulated environments. </li><li>Demonstrated experience delivering technical solutions that require validation, documentation, training and support in an FDA regulated environment. </li><li>Demonstrated experience planning, coordinating, and executing multiple projects concurrently. </li><li>Demonstrated experience in key compliance areas such as GxP, Annex 11, GAMP 5, and other compliance driven requirements. </li><li>Demonstrated ability to help develop and implement governance framework for IT Infrastructure, Applications, Security, Compliance, and general Operations/Support. </li><li>Excellent project management and delivery skills across multiple projects/sites with competing timelines. </li><li>Ability to influence the thinking of or gain acceptance of others in sensitive situations. Experience in negotiation and facilitation. </li><li>Demonstrated experience delivering technical solutions that require validation/testing , documentation, training and support in a regulated environment. </li><li>Candidate must have excellent written and oral communication skills. Proven ability to interact with executive level team members and build relationships. </li><li>Ability to function in a collaborative environment; sensitivity to others; high integrity; excellent judgment. </li></ul> <p>Preferred</p> <ul> <li>Strong analytical and problem-solving skills. </li><li>Superior organization, planning, and project management skills. </li><li>Excellent interpersonal, communication, and business partnering skills. </li><li>Ability to drive continuous improvement across the organization. </li><li>Ability to facilitate and resolve conflicts at both the senior and staff level. </li><li>Ability to operate in a cross-functional / matrixed environment </li></ul> <p>About Us</p> <p>Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.</p> <p>Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.</p> <p>Celcuity is an Equal-Opportunity Employer.</p> <p>Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $ - $. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.</p> <p>The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.</p> <p>Notice to Recruiters/Staffing Agencies</p> <p>Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.</p> <p>We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.</p> <p>Celcuity's receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.</p>