Training Compliance Manager

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The Training Compliance Manager works with quality management and HR management to develop, manage, and coordinate the Liquidia training department across all business units and to assure adherence to Liquidia SOPs, relevant GxPs, and applicable regulatory requirements. The Training & Compliance Manager will manage all aspects of the Liquidia Learning Management System (LMS) as the system admin and validation support. This role is responsible for maintaining the Liquidia training matrix and the tracking and reporting of training compliance metrics. The Training Compliance Manager will facilitate and support the development and delivery of general corporate training, cross-functional and departmental training, regulatory training, functional/role-based training as well as ad hoc training needs. The Training & Compliance Manager will evaluate the training program for ongoing improvement initiatives to identify gaps and needs in training, including those that may have resulted from deviations, Corrective Action Preventative Actions (CAPAs), audit findings, and other known issues or non-compliances. This person will act as the training & compliance subject matter expert (SME) and will provide support for regulatory inspections. Additionally, the Training & Compliance Manager will provide guidance to company personnel and project teams on training requirements and questions as needed, and perform duties in accordance with Liquidia’s values, policies, and procedures.

Job Responsibilities

• Works with HR and Quality Management to develop and implement companywide training initiatives, assesses progress, and focuses on the continuous improvement of training materials, programs, and processes.
• Drives training compliance initiatives and continually assesses compliance for opportunities for improvement.
• Ensures that the required technical, developmental, and regulatory training is implemented in order to achieve compliance, business objectives, and development of employees.
• Establishes and manages the LMS to ensure employee training is appropriately assigned and maintained in a current status.
• Assists with configuration and validation activities for the LMS, as well as communication with and management of the LMS vendor.
• Manages the training compliance metrics for all Liquidia processes and procedures.
• Performs training of personnel as required (i.e., hands-on, instructor-led, workshops, etc.).
• Develops new training procedures and revises existing procedures as required.
• Communicates the requirements for training to new hires and current staff and provides follow-up on outstanding action items and non-compliances.
• Develops and identifies key performance indicators (KPIs) and provides reports to management with training metrics and other training compliance information as required.
• Maintains the training schedules and the training matrix.
• Works closely with management to evaluate and identify training needs and makes recommendations on training material and methodology.
• Establishes and maintains relationships cross functionally and works with business unit heads and department managers from all functional areas to develop, manage, and maintain applicable trainings.
• Assesses training program for inefficiencies and gaps and implements measures to improve training and compliance.
• Performs all other duties as assigned.

Job Requirements

Education and Experience

• Minimum requirement of a bachelor’s degree or equivalent combination of experience and education in a scientific discipline is preferred.
• At least five (5) years of relevant GxP experience within the training/compliance, quality, or HR functions in a Pharmaceutical/Biotech industry, with increasing responsibility in a GxP compliance/training related role.
• Understanding of the drug and/or device development process and clinical trial phases.
• Experience working with an electronic Quality Management System (QMS), specifically the document management and learning management functions of an electronic QMS.
• Broad understanding of GxP guidelines and applicable GxP regulations

Knowledge, Skills, and Abilities

• Detail oriented with excellent communication and interpersonal skills who can communicate effectively with internal and external stakeholders, and operate as part of a collaborative team to negotiate effective solutions, manage multiple priorities, and deliver high quality results.
• Proven track record of participating as a member of a cross-functional team on quality and process improvement initiatives.
• Excellent verbal and written communication skills who is able to prioritize responsibilities, manage multiple projects, and deliver quality results through effective planning and time management.
• Strong analytical and writing skills to identify issues, solve problems and document them appropriately.
• Ability to manage and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities.
• Consistently exercises discretion and independent, sound judgment in the performance of the duties described above.
• Experience working with computer systems and software including Microsoft Office Suite (MS Word, Excel and PowerPoint), Adobe and electronic Quality Management System – Document and Training Management Modules.
• Requires a highly motivated, resourceful, creative, decisive self-starter that can set goals, shift priorities, and work collaboratively to ensure regulatory compliance and high-quality results.
• Highly motivated individual with excellent problem-solving skills and the ability to make difficult decisions and provide sound Training Quality/Compliance direction to personnel as applicable.

Job Benefits

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note :

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.