Director, Electronic Systems Compliance & Validation

Job Description

Job Description

Salary : $200,000

Title : Director, Electronic Systems Compliance & Validation

Location : Remote

Position Summary :

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 Companys IT GRC framework and roadmap, aligning with industry standards to uphold the integrity, security, and compliance of IT systems and data.

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.

Responsibilities : Compliance

• 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.
• 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.
• Evaluates the adequacy and effectiveness of the companys information systems policies and controls.
• Supports implementation and maintenance of regulated electronic systems to ensure compliance with applicable regulations.
• Coordinates and tracks corrective actions resulting from internal or external audits.

Validation

Governance

Risk

Other

Qualifications :

Preferred :

About Us :

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.

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.

Celcuity is an Equal-Opportunity Employer.

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 $155,000 - $180,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidates geography, qualifications, skills, and experience.

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.

Notice to Recruiters / Staffing Agencies

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.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Celcuitys 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.

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