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Compliance Training Assoc Dir/Director

Philadelphia, PA

About the Position

Reporting to the Chief Compliance Officer, the Compliance Training Assoc Dir/Director is an integral member of the GxP Quality and Compliance team. The Position is responsible for supporting the implementation and maintenance of a quality and compliance program and operationalizing the components of the program in alignment with applicable laws and regulations and Cabaletta Bio SOPs and policies. The Training Assoc Dir/Director will develop, implement and continuously improve Cabaletta Bio’s Compliance Training Program to ensure regulatory and corporate compliance across all areas of the business. The Training Manager will provide additional writing and project support to the Compliance team as needed.

Responsibilities Include

  • Manage company -wide training program for corporate and GxP including devising a training strategy for the company
  • Build training programs from scratch (from the initial idea through planning, implementation, review, and outcomes analysis)
  • Design and deliver training courses and workshops, utilizing a variety of methods, (train the trainer, face to face and virtual courses)
  • Identify opportunities to develop employees and design and deliver new courses in response to employees’ needs
  • Understand employees’ training requirements and advise on the most appropriate solutions. Identify training and development needs through training needs analysis
  • Keep up to date with methods, tools and techniques which can be applied to achieve more effective learning and use this knowledge to propose innovative modes of delivery for employees
  • Identify training and development needs through job analysis, appraisal and regular consultation with line managers and human resources
  • Design and expand training and development programs based on the needs of Cabaletta and the individual
  • Work as a team to produce programs that are satisfactory to all relevant parties such as line managers, staff, and senior managers
  • Consider the costs of planned programs and keep within budgets
  • Plan and assess the 'return on investment' of any training or development program
  • Develop an effective induction program for new staff, contractors, and interns as appropriate
  • Monitor and review the progress of trainees through questionnaires and discussions with managers
  • Provide CCO with quarterly training compliance reports
  • Maintain awareness of upcoming changes in regulations to plan programs to update employees on the latest requirements.
  • Plan, develop and deliver training programs to ensure ongoing compliance.
  • Work independently, and effectively build collaborative cross-functional relationships.
  • Partner with and oversee 3rd party relationships.
  • Develop feedback mechanisms to ensure that employees understand compliance policies and directives and put instruction into practice.
  • Develop job aids as applicable to reinforce the messages from training courses.
  • Maintain comprehensive records of training for individuals or departments and provide reports to management as applicable.
  • Submit training records to regulators and provide support to mock and actual audits to demonstrate compliance.

Required Qualifications

  • Bachelor’s degree required, with preference for concentration in biomedical science, regulatory affairs, clinical research, nursing or related health sciences field.
  • At least four years of experience in pharmaceutical or related Compliance and Training functions.
  • Knowledge of federal research regulations and guidance, including but not limited to 21CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46 and ICH GCP guidance
  • Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships.
  • Effective presentation and writing skills - ability to clearly explain regulations and company compliance polices.
  • Ability to provide clear, pragmatic direction and advice regarding compliance issues.
  • Must be highly organized and able to work independently.
  • Strong team orientation and passion for continuous self-development.
  • Experience in a startup corporate setting highly desirable.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.