change-control jobs in San Diego

Director-level role managing data center operations, infrastructure, and associated teams at a healthcare organization. Responsible for on-premises and hybrid infrastructure environments, network architecture, disaster recovery, business continuity, compliance with healthcare/security regulations, and supervising assigned staff.…See more Requires 10+ years of data center/infrastructure experience, 8+ years in supervisory roles, and demonstrated expertise in enterprise networking, cloud platforms, virtualization, and IT service management.

Provide IT infrastructure, application, and technical support for laboratory environments in life sciences/pharmaceutical/biotechnology settings. Install, configure, maintain, and troubleshoot laboratory IT systems including LIMS, ELN, LES, CDS applications, laboratory instruments, Windows servers, Active Directory, and networking.…See more Support GxP-regulated environments, system validation, change control, and audit activities while ensuring security, availability, and data integrity.

This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.…See more The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.

Associate Director of Technical Operations at a biopharmaceutical company overseeing CMC (Chemistry, Manufacturing, and Controls) strategy for a diverse portfolio of small-molecule drugs in development through commercialization. Leads external manufacturing partners (CMOs), manages technology transfer and scale-up activities, ensures cGMP compliance, and authors regulatory submissions.…See more Requires 8+ years of progressive CMC and drug development experience with demonstrated leadership across multiple CMC disciplines and small-molecule, peptide, and biologic manufacturing.

The QA Associate II supports quality assurance operations in a regulated manufacturing environment, ensuring materials, processes, and products comply with cGMP and company procedures. Responsibilities include reviewing batch records and analytical data, assessing deviation and CAPA closure, conducting GMP documentation reviews and line clearance inspections, and supporting material/equipment qualification and audit activities.…See more The role requires independent judgment on routine quality decisions, cross-functional collaboration with Manufacturing, QC, and other departments, and the ability to draft and revise SOPs and quality documentation. A Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment are required; cell therapy, aseptic technique, and cleanroom experience are valued.

The QA Associate II reviews manufacturing batch records, analytical test results, and quality documentation to ensure compliance with cGMP and company procedures. Responsibilities include assessing deviations and CAPAs, conducting line clearance inspections and process observations, supporting material and equipment qualification, and participating in audits and investigations.…See more The role requires judgment in routine and moderately complex quality decisions, cross-functional collaboration, and SOP documentation in a regulated biopharmaceutical manufacturing environment.

As an MDM Solutions Engineer, you will serve as a product and delivery lead for Reltio and/or Informatica MDM platforms in Life Sciences, designing and maintaining master data models for HCP/HCO, accounts, affiliations, and product hierarchies. You will configure identity resolution, survivorship, and stewardship workflows; establish data quality rules and monitoring; and partner with cross-functional stakeholders to drive adoption and governance operations.…See more The role requires 5+ years of data management/MDM experience with 2+ years of hands-on Reltio or Informatica MDM implementation, plus deep knowledge of Life Sciences commercial domains and data governance frameworks.

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment.…See more Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.

This role supports a US Navy Program Office as a Configuration Management Specialist, leading all CM duties including development of configuration baselines, Cost Analysis and Requirements Description (CARD) documentation, configuration tracking and control, and technical oversight of configuration workflows. The specialist prepares Engineering Change Requests (ECRs), establishes disciplined CM processes, maintains CM data, and participates in the Configuration Control Board (CCB).…See more The position requires at least ten years of configuration management and CCB process experience, a Bachelor's Degree, and an active Secret security clearance.

The Software Configuration Management Specialist plans, implements, and maintains SCM processes, tools, and environments for complex software and systems development programs. Responsibilities include establishing and managing software baselines, enforcing change control processes, ensuring traceability across requirements/design/code/test artifacts, and leading SCM process improvements and automation initiatives.…See more The role requires hands-on experience with version control systems (Windchill, Atlassian products), build scripting (Bash, Perl, Shell), and knowledge of software development lifecycles and configuration management standards (EIA-649, MIL-HDBK-61). Success demands strong analytical skills, cross-functional collaboration, and the ability to mentor junior staff on SCM best practices.

QA Associate II supports manufacturing operations at a cell-therapy biotech company, reviewing batch records, analytical results, and quality documentation to ensure compliance with cGMP and company procedures. The role involves assessing deviations and CAPAs, conducting line clearance inspections, performing GMP documentation reviews, and supporting material/equipment qualification and audit activities.…See more The person will exercise judgment on routine and moderately complex quality issues, escalate concerns appropriately, and collaborate cross-functionally with Manufacturing, QC, and Facilities. The position requires a Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment.

Support Computer System Validation (CSV) activities for GxP-regulated pharmaceutical and medical device systems, including validation planning, test execution, documentation, and compliance verification against FDA regulations and 21 CFR Part 11. Execute validation test scripts, document results and deviations, conduct impact and risk assessments, and collaborate with cross-functional teams to ensure systems meet regulatory and data integrity requirements.…See more Maintain validation records, support change control and CAPA activities, and identify compliance gaps in regulated computerized environments.

This role combines prompt engineering expertise with AI system governance and enterprise adoption strategy. The engineer will optimize LLM performance across platforms (OpenAI, Anthropic), design and configure AI agents and chatbots with knowledge grounding, and establish prompt governance frameworks and best practices.…See more Success requires 5+ years in AI/ML systems, 2+ years of hands-on prompt engineering, and demonstrated ability to evaluate AI performance, manage knowledge systems, and guide enterprise clients through AI tool adoption and deployment.

Staff Quality Engineer for a medical device manufacturer responsible for owning and continuously improving the Quality Management System across the full product lifecycle. The role involves coordinating QMS processes and documentation, leading design control programs, managing change control reviews, directing CAPA activities, handling complaints and supplier qualification, and leading internal audit programs.…See more Requires 8–10+ years of medical device quality experience, 3+ years in quality system auditing, and strong expertise in ISO quality systems and FDA-regulated device standards.

Senior Software/Firmware Systems Engineer and Architect will design, architect, and lead complex real-time embedded and mission-critical systems for space, missile defense, and high-reliability platforms. Responsibilities include defining system architecture and requirements, leading cross-functional teams through design and test reviews, integrating software/firmware payloads, and ensuring consistency across digital engineering artifacts.…See more The role requires 7–12+ years of embedded systems experience with expertise in microcontrollers, FPGAs, communication protocols (RS-422, I²C, GigE, SPI, TCP/UDP, MQTT, Modbus), and formal verification/validation processes; strong technical leadership and customer-facing communication skills are essential.

Senior Software Engineer responsible for architecting and executing deployment of an AI-enabled product suite to government-authorized cloud environments (IL6, JWICS). The role spans full-stack development (React/Node/Python), DevSecOps hardening, security controls implementation (NIST SP 800-53, OSCAL), and compliance documentation.…See more You'll mentor engineers on secure design, translate between government compliance requirements and engineering execution, and serve as the technical subject matter expert guiding cross-functional teams through a complex, regulated deployment.

Senior Systems Engineer responsible for leading complex space-based systems and payload development, including formal verification and validation activities. The role requires designing, integrating, and testing defense systems while collaborating across engineering disciplines and customer interfaces.…See more You will apply systems engineering principles (V-model, MBSE), develop AI&T plans, manage configuration and change control, and generate technical documentation using digital engineering tools. The position requires 12+ years of engineering experience (or equivalent with advanced degrees), an active Top Secret/SCI clearance, and proven ability to lead integrated product teams on space-qualified hardware programs.

This Senior AI Software Program Manager role owns end-to-end planning, execution, and delivery of AI-based product programs—managing schedules, scope, budget, and resources while translating organizational strategy into product roadmaps. The individual coordinates across product management, technology teams, systems, and software leads to ensure timely, quality delivery; manages risk mitigation and stakeholder reporting; and drives process improvements and compliance across interdepartmental efforts.…See more The role requires a Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, or related field, plus four years of related program or project management experience.

Lead day-to-day technical project delivery for Distribution Operations initiatives including outage management, solar/battery data integrations, forecasting, automation, and analytics. Transform technical requirements into delivery plans, sprint backlogs, and release milestones while coordinating work across data engineers, architects, cybersecurity teams, and vendors.…See more Manage project controls, scheduling, defect tracking, and comprehensive documentation across integrations, ETL/ELT pipelines, cloud analytics, and Power Platform solutions. Facilitate design reviews, support operational readiness, and ensure technical solutions meet engineering rigor and real-world operational needs.

This role supports Naval Air Systems Command (NAVAIR) at NAS North Island, California, developing and maintaining configuration management systems, tools, and documentation for RDT&E lab environments. Responsibilities include managing cybersecurity configuration toolsets, creating and modifying CM plans and policies, maintaining configuration baselines and libraries, and collaborating with IT operations teams.…See more The candidate will use tools such as Jira Projects, Jira Helpdesk, SharePoint, Microsoft Planner, and Power Apps to track controlled documentation and support change control processes across the system lifecycle.

Configuration Management Analyst supporting Naval Air Systems Command at NAS North Island, responsible for developing and maintaining configuration management systems, CM plans, and cybersecurity toolsets for RDT&E lab environments. Duties include lifecycle management of hardware and software configuration items, maintaining a configuration management library (lab accreditation artifacts, change control, network diagrams, incident reports), and collaborating with IT operations to ensure accurate configuration information.…See more Requires 3+ years of configuration management experience, proficiency with Atlassian Jira, Microsoft SharePoint, Planner, Office 365, and Power Apps, plus strong organizational and analytical skills.

This Quality Assurance Specialist II role supports clinical trial projects at a pharmaceutical CDMO, ensuring compliance with cGMP and SOPs throughout the product lifecycle. Responsibilities include pre- and post-execution batch record review, authoring/updating QA and compliance documentation, participating in investigations and deviation writing, and reviewing change controls.…See more The candidate must demonstrate strong knowledge of GMP environments, proficiency with MS Office (especially Excel) and ERP systems like JD Edwards, and 5–10+ years of relevant pharmaceutical QA experience depending on education level.