Description:
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.
As a compliance leader, you will collaborate cross‑functionally with Quality, Business Technology, Data, and business stakeholders to incorporate operational insights and regulatory expectations into practical, risk‑based compliance procedures and oversight that enable compliant business outcomes
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 and 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.