Oversee and optimize operations of the Business Administration Office at Princeton Hydro. Leading compliance and operational efficiency across multiple states as a seasoned professional.
About the role
- Director, IT Quality Compliance at Bicara Therapeutics ensuring IT systems comply with global regulations and GxP standards. Leading teams to maintain quality management and risk assessment strategies.
Responsibilities
- Lead the development and execution of IT quality and compliance strategies aligned with enterprise risk and regulatory requirements.
- Oversee IT governance, risk assessments, and internal controls to ensure compliance with GxP, SOX, GDPR, and related regulations.
- Manage computer system validation activities, including initial validation, change control, and periodic reviews.
- Support internal and external audits, regulatory inspections, and RFI responses across global regions.
- Maintain and enhance the IT Quality Management System (QMS), including controlled documents such as policies, SOPs, work instructions, and templates.
- Co-own and manage the Software Life Cycle (SLC) methodology; provide training on SLC processes and deliverables.
- Define and report on KPIs related to IT compliance, risk, and audit readiness.
- Collaborate with all departments to ensure cross-functional compliance.
- Lead the development of a risk-based validation methodology and a harmonized Software Life Cycle (SLC) framework across IT systems.
- Define and tailor validation approaches for emerging technologies such as AI, cloud platforms, and advanced analytics, ensuring scalability and regulatory compliance.
- Implement standardized tools for computer systems validation to improve efficiency, reduce compliance costs, and protect company assets.
- Foster a culture of quality and accountability across IT and business teams through effective leadership, communication, and stakeholder engagement.
Requirements
- Bachelor’s Degree required (ex. science based, operations research, technology, etc.)
- 10+ years’ experience in an FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology) including: 5+ years’ experience leading/managing teams, developing strategies, execution of projects.
- 5+ years leading large IT validation projects.
- Expert in various validation methodologies (SDLC), and their implementation in an IT organization.
- Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GxPs).
- Creative approach to resolving technical issues, and balancing IT and business needs.
- Strong interpersonal skills and ability to command respect of others.
- Ability to interact with all levels within the organization.
- Program & Project Management experience – ability to plan, organize, and execute work across multiple initiatives.
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