QA Learning and Development (GCP/ICH) - Open Level
Trialspark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
Our Quality Assurance (QA) team at Trialspark is looking for someone to create and drive a comprehensive quality learning strategy. This role is embedded in our Quality Assurance organization to deliver learning solutions that ensure proper oversight and compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, Health Authority regulations, quality parameters and effectiveness checks, safety of patients, data integrity, and business goals.
This is an open-level position so based on your experience we will calibrate on exact title:
- Manager: 3 - 5 years of experience
- Senior Manager: 5 - 7 years of experience
- Director: 8 years+
- Develop and lead a robust end-to-end Quality Learning and Development program, providing leadership across GCP/ICH L&D transformation;
- Partner with leadership to develop and influence strategies for identifying and prioritizing near and long term large scale quality performance improvement initiatives;
- Drive a blended approach to learning including face-to-face programming complemented by the use of innovative learning methods and technology to transform Quality learning outcomes.
- Create and lead a Quality learning community to help build capability, consistency and access to tools for TrialSpark employees;
- Keep abreast of regulatory/policy developments and industry trends, benchmarking externally and influencing TrialSpark L&D Quality strategies as appropriate;
- Develop, implement, and ensure adoption of structured clinical core learning and development curricula and associated programming;
- Maintain a business support model to provide appropriate L&D support for TrialSpark with a focus on GCP and regulatory related training;
- Establish and maintain documented business processes for development of Quality training across TrialSpark;
- Liaise within Quality Assurance on audit and inspection findings and opportunities based in inspections;
- Assess and take necessary training-related action related to TrialSpark CAPAs.
- Serve as organizational point of contact and subject matter expert for Quality L&D related questions.
- Oversee portfolio of Quality L&D work, including management of vendor related issues.
- Bachelor’s degree from an accredited institution required
- Experience in a learning and development capacity in the regulated pharmaceutical or healthcare industry;
- Thorough understanding of all phases of drug development (I-IV);
- Experience in the development and delivery of technical training programs;
- Demonstrated experience leading and managing teams/organizations.
- Pragmatic; effectively balances timelines with thoroughness of quality assessments,
- Business judgment; assesses CAPA risk of impacting quality or safety of a trial and drives appropriate action
- Tenacity; creates a sense of urgency for achieving results
- Shared success; drives cross-functional understanding of quality/training trial needs
- Customer Focus: builds trust, develops new customer oriented solutions focused on training and compliance needs
- Adherence to all relevant SOPs, regulatory policies and TrialSpark policies and procedures
- Ability to strategically influence at the executive level
- Demonstrated ability to collaborate and influence cross functionally
- Demonstrated competency in developing and implementing strategic plans
- Deep understanding across Clinical Operations
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.