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Senior Manager/Associate Director, GxP Systems

Needham, MA

Senior Manager/Associate Director, GxP Systems

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors.  Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early – to late-stage disease.

Join our rapidly growing Company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers.

Please visit www.Candeltx.com for additional information.

This is an exciting time to join Candel Therapeutics as we are growing and are almost finished with construction for our first manufacturing suites/labs.

If you are a team player with a sense of urgency who likes to work in a fast-paced environment, you may be a good fit for Candel Therapeutics.

Reporting to the Senior Director, Quality Lead, you will provide hands-on expertise in the day-to-day management of data and document control for GxP Systems.

Responsibilities:

  • Responsible for monitoring overall GxP system effectiveness - continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
  • Provide and coordinate training in support of GxP Systems.
  • Actively participate in the preparation, selection, and auditing of GxP Systems.
  • Propose, initiate, and prepare SOPs and other governance documents in support of computer system validation efforts and routine GxP management.
  • Review, approve, and/or administer critical compliance documents in support of GxP system management.
  • Perform vendor audits and oversight related to GxP technology.
  • Conduct cross-functional investigations, risk management, and mitigation plans for computer system validation and GXP systems.
  • Plan and manage projects in support of change control, CAPA’s etc.
  • Develop and measure quality metrics to drive consistent quality activities.

Requirements:

  • Bachelor's degree in the Life Sciences or related technical experience and expertise.
  • Ten+ years of relevant clinical research and systems experience including managing GxP quality systems in the Pharma/Biotech industry.
  • Significant experience with digital and paper based QMS and eTMF solutions.
  • Diverse, Quality operations experience across non-clinical, clinical, and regulatory oversight activities.
  • Reliable subject matter expert for quality and GxP systems-related matters.
  • Excellent cross-functional partnership skills to work across an organization to achieve business objectives.
  • Collaborates and communicates transparently, listening and understanding effectively, and inviting response and discussion with key stakeholders.
  • Demonstrates critical thinking and problem solving to anticipate and work with others to resolve issues proactively.
  • Ability to establish professional relationships, built on competence, mutual trust, and respect, that influence others and resolve conflicts effectively.
  • Comfortable in a fast paced, results-driven, accountable environment.
  • Strong project management skills
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