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Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
The Director, Customer Enablement & Learning will manage customer training and learning experiences for Applied's software, focusing on strategies that increase customer proficiency and adoption while leading a dedicated team.
Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
The Sr. Associate Product Manager will manage product strategies, conduct market research, align product backlogs, and liaise with stakeholders to enhance solutions in the insurance industry.
Top Skills:
AISaaS
Artificial Intelligence • Consumer Web • Digital Media • Information Technology • Social Impact • Software
The Senior Copywriter will be responsible for creating compelling marketing content, maintaining brand voice, and collaborating with cross-functional teams on integrated campaigns and product launches.
The GCP Project Manager is responsible for leading and coordinating GCP Inspection Readiness activities and serving as the primary liaison between the company and external consulting partners. This role ensures that the organization, its systems, and teams are fully prepared for regulatory inspections through proactive planning, coordination, and continuous improvement.
The ideal candidate brings a strong understanding of regulatory inspections, exceptional project management skills, and the ability to communicate effectively across internal and external stakeholders.
Location: Emeryville, CA (Hybrid twice a week) or Remote with travel
Department: Clinical Ops / Quality Assurance
Reports to: Sr. Director, Clinical Operations
Hourly Range: $80/hr - $100/hr
Duration: 6+ months
Travel: up to 25%
Responsibilites
- Coordination of GCP Inspection Readiness Activities
- Develop and execute an integrated inspection readiness plan encompassing all applicable functions.
- Serve as the primary point of contact for external consultants and inspection readiness vendors, overseeing timelines, scope, and deliverables.
- Coordinate scheduling, logistics, and materials for mock inspections and inspection readiness assessments.
- Partner with consulting teams to ensure consistent feedback, actionable findings, and alignment on readiness priorities.
- Collaborate closely with Kyverna QA to align inspection readiness activities, inspection support, and post-inspection follow-up.
- Drive follow-up actions from mock inspections and ensure effective implementation of corrective measures.
- Support the planning and execution of regulatory inspections, including coordination of front room/back room operations, SME scheduling, and document management.
- Manage inspection requests, communications, and documentation flow in real time during inspections.
- Maintain clear communication with leadership and cross-functional teams throughout the inspection process.
- Develop and maintain inspection readiness dashboards, metrics, and status reports for leadership visibility.
- As needed: Coordinate and track inspection findings, responses, and CAPA implementation; partner with Quality, Clinical, Technical Operations, and Regulatory teams to ensure timely closure of commitments.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related discipline (advanced degree preferred).
- Minimum of 7+ years of experience in the biopharmaceutical industry.
- Proven track record of working with or managing external consulting firms for mock inspections or audit preparation.
- Strong understanding of ICH GCP guidelines and quality system principles.
- Exceptional project management and organizational skills with the ability to manage multiple, complex projects simultaneously.
- Strong stakeholder management and communication skills, including experience interfacing with senior leadership and external partners.
- Ability to translate consultant feedback into actionable internal plans.
- Proficiency with Microsoft Office, Smartsheet, and document/QMS systems (e.g., Veeva, DotCompliance).
- Collaborative, proactive, and detail-oriented approach with a focus on operational excellence.
- Preferred Qualifications
- PMP certification or equivalent project management training.
- Demonstrated experience managing inspection readiness or regulatory inspections with FDA, EMA, or other health authorities.
- Experience in cell therapy and/or rare disease programs.
- Familiarity with global inspection processes and remote inspection technologies.
- Strong analytical mindset and commitment to continuous improvement.
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
