[Hiring] QMS Training Manager @Celcuity Inc.

Role Description

We are seeking a QMS Training Manager who will report to the Director, Quality Management Systems. You will focus on the organization, facilitation, and management of GxP and corporate training curricula at Celcuity.

• Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin.
• Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS.
• Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials.
• Coordinates with hiring managers to launch Training Plans for new or changing learner roles.
• Works with hiring managers and HR to review and approve onboarding forms.
• Coordinates information about training and QMS orientation for new hires; adds new hires to appropriate training curricula and learner roles per their onboarding training plan.
• Collects signed new or updated CVs and job descriptions and uploads them to the associated Job Title in the eQMS.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in the life sciences or related field; or relevant experience.
• Five plus (5+) years of experience in GxP training curricula design and management within an electronic QMS. Veeva experience preferred.
• Proficiency and experience with electronic Learning Management Systems, Veeva strongly preferred.
• Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP.
• Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
• Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
• Attention to detail and ability to manage multiple processes and documentation requirements.
• Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.

Benefits

• Anticipated base pay range is $105,000 - $128,000.
• Annual performance incentive bonus.
• New hire equity package.
• Medical, dental, vision insurance.
• 401(k) match.
• PTO and paid holidays.

Company Description

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

Celcuity is an Equal-Opportunity Employer.