Manager, Compliance overseeing federal clients' FOIA compliance and federal contracting adherence. Leading strategic guidance and compliance operations with a focus on effective audits and training.
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.
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Compliance Officer conducting onsite and remote branch examinations at Aviso Wealth. Join our dynamic team improving the financial well - being of Canadians through compliance oversight.
Group Regulatory Policy Manager overseeing regulatory policy strategy and advocacy at Lloyds Banking Group. Collaborating across teams to enhance regulatory insights and communications.
Compliance Assistant Manager supporting regulatory and business change activities at Western Alliance Bank. This role involves oversight, guidance, and collaboration across multiple business lines.
Compliance Specialist in research administration at WashU. Developing knowledge of programs and ensuring compliance with policies and regulations.
Global Regulatory Lead managing regulatory strategies and compliance for new pharmaceutical products. Collaborating with global teams and authorities throughout the product lifecycle.
Manager of Software Audit overseeing software license compliance and SAM capabilities at Gap Inc. Collaborating cross - functionally to analyze software usage and enforce adherence to licensing requirements.
Security Worker responsible for maintaining security at Kauffman Stadium. Conducting patrols, inspections, and collaborating with local authorities for safety management.
Director of US Regulatory Affairs leading end - to - end labeling processes in a biopharmaceutical company. Collaborating with cross - functional teams ensuring compliance in labeling development and management.
Compliance Officer providing proactive regulatory compliance and risk advisory for Canadian Reinsurance businesses. Supporting local teams and managing compliance frameworks for Swiss Re Canada.