As an Associate Director, Systems Transformation, you will be responsible for defining, maintaining, and overseeing enterprise systems compliance policies and procedures that support Business Technology and related operational processes in a regulated environment. You will own ESQC procedures and training content, provide compliance oversight for controls and issue management, and ensure consistent, inspection‑ready execution of compliance expectations.
Responsibilities
* Own selected BT processes within the ESQC scope such as SDLC, BT Deviation, and the BT Document Management System
* Draft, revise, and maintain enterprise systems compliance policies and procedures within ESQC scope, including associated training, ensuring alignment with regulatory and internal quality requirements.
* Work within a complex regulatory environment including GxP, finance, data privacy, AI, and cybersecurity laws and regulations; collaborate with stakeholders to translate requirements into clear, actionable guidance. Provide guidance for complex initiatives, including new system capabilities or emerging technologies, to ensure compliance requirements are understood and met.
* Train/coach founders on Quality Assurance principles and application of these within the Business Technology space.
* Oversee compliance aspects of deviations, CAPAs, and systemic issues to ensure timely, risk‑based resolution.
* Monitor compliance performance indicators, prepare metrics and KPI data to present at senior governance/management reviews, and drive continuous improvement of procedures and oversight processes.
* Support inspection readiness activities and participate in internal and external audits.
* Identify, propose, drive, and implement process simplification and technology solutions through cross‑functional collaboration.
* Perform additional responsibilities as assigned by the manager, aligned with organizational needs.
Required Education, Experience, and Skills
* Bachelor’s degree in Life Sciences, Information Technology, Engineering, or a related discipline (or equivalent experience).
* 8+ years of experience in Quality, Compliance, or regulated technology‑enabled environments.
* Proven experience in policy and procedure development, compliance oversight, and cross‑functional collaboration.
* Strong understanding of GxP compliance and inspection readiness expectations.
* Excellent written and verbal communication skills.
Preferred Education, Experience, and Skills
* Experience operating within enterprise or global compliance organizations.
* Familiarity with compliance oversight of computerized systems and business technology processes.
* Demonstrated ability to influence stakeholders and drive compliant outcomes without direct authority.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
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