GCP Compliance Manager

4 weeks ago


San Diego, California, United States Trova Talent Full time
GCP Compliance Manager Job Description

Trova Talent is seeking a highly skilled GCP Compliance Manager to join our team. As a key member of our organization, you will be responsible for providing compliance oversight and ensuring the highest standards of quality in our clinical trials.

Key Responsibilities:

  • Develop and implement systems to advance GCP compliance within the organization
  • Provide strategic support to clinical study teams and establish measures to reduce compliance risks
  • Collaborate with Quality Assurance, Regulatory Affairs, and the Clinical team to develop internal policies and standard operating procedures
  • Manage eTMF implementation, maintenance, and training activities
  • Ensure qualification of GCP vendors and manage the GCP audit calendar
  • Perform TMF compliance checks and support Inspection Readiness activities
  • Assist in Trial-Specific Training and assess/ensure proper documentation of Clinical Operations process deviations
  • Collaborate with clinical trial teams to identify operational issues and opportunities for improvement
  • Manage clinical CAPAs and conduct root cause investigations related to clinical deviations
  • Reviews essential documents for adherence to GCPs

Requirements:

  • Minimum of bachelor's degree in a scientific or related discipline
  • At least 3-5 years of eTMF experience, including experience in study start-up, study maintenance, and quality reviews
  • 6+ years' experience in pharma with relevant experience in clinical trials related roles
  • Experience performing quality assurance and/or quality management activities
  • Experience with GCP vendor and site audits required
  • Prior experience with BIMO inspections is strongly preferred


  • San Diego, California, United States Trova Talent Full time

    Job DescriptionOur client is seeking a GCP Compliance Manager to provide strategic support to clinical study teams and ensure compliance with Good Clinical Practice (GCP) guidelines. The ideal candidate will have experience in eTMF implementation, maintenance, and training, as well as a strong understanding of ICH/GCP guidelines.Key Responsibilities:Develop...


  • San Diego, California, United States Meet Full time

    Role Overview:Meet is seeking a Sr. Director to oversee GCP/GVP compliance across ongoing clinical studies, collaborating with multiple teams to ensure quality is integrated throughout the clinical program lifecycle.Key Responsibilities:Develop and maintain GCP QA programs and policies.Ensure compliance with health authority regulations.Act as the GCP QA...


  • San Diego, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly experienced Associate Director, GCP Quality Assurance to join our team at BioSpace, Inc. This role will be responsible for managing the clinical quality function, ensuring GCP compliance, and collaborating with cross-functional teams to drive the success of our clinical programs.Key ResponsibilitiesDevelop and implement GCP...


  • San Diego, California, United States Avidity NanoMedicines Full time

    Job Summary:The Associate Director, GCP Quality Assurance, will oversee the clinical quality function, ensuring GCP compliance and implementing quality management systems. This role will collaborate with various departments to ensure effective communication and working relationships.Key Responsibilities:Develop and implement GCP quality management systems,...


  • San Diego, California, United States Arrowhead Pharmaceuticals Full time

    Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking a Senior Quality Manager, Vendor Compliance to join our Quality and Compliance department.The purpose of this position is to manage and oversee all aspects of Vendor Quality management activities, including...


  • San Francisco, California, United States Crinetics Pharmaceuticals Full time

    Crinetics Pharmaceuticals: A Leader in Endocrine TherapiesWe are a pharmaceutical company based in San Diego, California, dedicated to developing innovative therapies for people with endocrine diseases and endocrine-related tumors. Our team of scientists is driven by a passion for improving lives through rigorous innovation.Job Summary:The Senior Specialist,...


  • San Francisco, California, United States TEKsystems Full time

    About TEKsystems Global ServicesWe are a team of experts in Full-Stack Technology Services, Talent Services, and real-world application, working with progressive leaders to drive change.As an industry leader, we help clients activate ideas and solutions to take advantage of a new world of opportunity.We partner with customers across the globe to own change...


  • San Francisco, California, United States Sparktek Full time

    Job Title:Sr Platform Network Engineerwith Strong GCP experienceLocation:Mountain View, CA [Needs to be onsite for 1 week once in a quarter on your own expenses]Job Type: ContractJob Description:We are seeking a Senior GCP Platform Engineer with expertise in networking to join our team. In this role, you will be responsible for designing, implementing, and...


  • San Diego, California, United States BioSpace, Inc. Full time

    Job SummaryThe Associate Director, GCP Quality Assurance, will oversee the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance.Key Responsibilities Develop, implement, and maintain GCP quality management systems, policies, and SOPs...


  • San Diego, California, United States Avidity NanoMedicines Full time

    Job Summary:The Associate Director, GCP Quality Assurance, will play a key role in managing the clinical quality function by supporting and providing oversight of clinical trials and clinical activities. This individual will establish and manage clinical quality systems, ensuring GCP compliance and collaborating cross-functionally with various departments...


  • San Francisco, California, United States Compliance Solutions Inc Full time

    About Compliance Solutions IncWe are seeking a highly skilled Compliance Security Specialist to join our team. As a key member of our security department, you will be responsible for understanding security and AI safety expectations, as established by regulators, customers, and industry norms.Key Responsibilities:Understand the breadth of our security...


  • San Diego, California, United States Family Health Centers of San Diego Full time

    Job DescriptionFamily Health Centers of San Diego is seeking a Compliance Manager for our Program for All-Inclusive Care for the Elderly (PACE).Key ResponsibilitiesEnsure compliance with federal, state, and other applicable regulations for the FHCSD PACE program.Develop and maintain a compliance program, perform risk assessments, audits, and ensure...


  • San Francisco, California, United States Nurix, Inc. Full time

    Clinical Quality Assurance Manager **Job Summary** We are seeking a highly experienced Clinical Quality Assurance Manager to join our team at Nurix Therapeutics, Inc. The successful candidate will be responsible for ensuring the quality and compliance of our clinical trials, working closely with Clinical Operations, Clinical Development, CMC, Medical...


  • San Diego, California, United States Parker Hannifin Corporation Full time

    Job Summary:The Senior Manager, Trade Compliance will be responsible for managing the export and import program of the business, as well as conducting assessments and audits of the business's compliance with export and import laws and regulations.Key Responsibilities:Implementation and maintenance of the Trade Compliance program within the business,...


  • San Jose, California, United States ClinDCast Full time

    Position Title: Senior Java Lead DeveloperLocation: San Jose, CAPosition Summary:We are seeking a highly skilled and experienced Senior Java Lead Developer with expertise in Google Cloud Platform (GCP) to lead our dynamic team in shaping the future of healthcare. The ideal candidate will have a strong background in Java development, leadership experience,...


  • San Diego, California, United States Family Health Centers of San Diego Full time

    Transforming Healthcare through Compliance ExcellenceFamily Health Centers of San Diego (FHCSD) is a leading provider of exceptional healthcare services, dedicated to serving underserved communities with limited healthcare options. As a Compliance Manager for our Program for All-Inclusive Care for the Elderly (PACE), you will play a pivotal role in ensuring...

  • Program Manager

    4 weeks ago


    San Diego, California, United States BD Full time

    Job Description SummaryWe are a global medical technology company that advances the world of healthTM. Our purpose is to make a meaningful difference in the lives of our customers and patients. We are seeking a highly driven cross-functional leader to drive projects critical to international growth of our Dispensing Solutions business.The Senior Program...

  • GCP Data Engineer

    4 weeks ago


    San Francisco, California, United States Tekfortune Inc Full time

    Job Description:At Tekfortune Inc, we are seeking a highly skilled GCP Data Engineer - Cloud Computing Expert to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and maintaining large-scale data processing systems on Google Cloud Platform.Key Responsibilities: Provide technical guidance to a team of...


  • San Diego, California, United States Modular Medical Inc Full time

    Job Title: Clinical Study ManagerModular Medical Inc is seeking a highly skilled Clinical Study Manager to oversee the planning and execution of clinical studies. The ideal candidate will have a strong background in clinical research and experience managing medical device and/or combination products clinical research studies.Key Responsibilities:Develop and...


  • San Diego, California, United States Platform Science Full time

    About the RoleThe Senior Product Manager of Compliance is responsible for supporting products that exist in an ever-changing legal landscape and fast-paced startup environment. This requires monitoring of regulatory developments and the ability to deliver value through upholding compliance as a priority through our ELD, DVIR, and Safety products. This also...