Black Diamond Therapeutics Inc GxP Training Manager/Sr. Manager Quality Contractor in Cambridge, Massachusetts
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of MasterKey therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single therapy that targets a specific family of mutations, termed a MasterKey therapy.
Responsible for overall development, management, and administration of BDTx GxP training program/process to ensure state of control and compliance readiness. In addition, this role will be responsible for the analysis, development, delivery, and completion of various training related activities associated with the implementation of a new GxP electronic Quality Management System (eQMS). This role will collaborate cross functionally with core project team members, GxP stakeholders and external business partners to ensure process is current, standardized, in a state of compliance and aligned with industry best practices.
Responsible for administration and management of GxP Training Program and ensuring employees on-boarding and annual objectives are met and are compliant with their training requirements.
Responsible for supporting the organization in ensuring all appropriate personnel are trained in current, effective procedures pertaining, and in accordance with Standard Operating Procedures (SOPs), cGxP’s and applicable FDA and other ex-US health authority standards
Maintain employee training files, both paper and electronic and ensure training records are readily available
This is a critical position that will help ensure all GxP related training activities, milestones and target due dates are achieved on time and assures training success.
Work with Document Control to ensure that SOP training is rolled out to appropriate personnel
Independently administer and manage the Training Program in the electronic Learning Management System (eLMS) when established.
Work with document authors to create knowledge assessments and implement in eLMS
She/he measures and reports-on the state-of-control of the training System to management both informally and as part of formal metric reviews.
Provides support to teams in defining/designing/delivering/deploying targeted training.
Handles souring/producing, evaluating, and administering of online learning resources when requested/applicable.
Responsible for managing delivery of instructor-led training to team members in both virtual and traditional group presentation settings
Engaging directly with various departmental representatives to create and maintain department and role-based training curricula, learning plans, on-the-job programs and implement in the eLMS.
Build and maintain working relationships with subject matter experts to create, review, and edit training materials, facilitating the timely accomplishment of learning related deliverables
Review, approve hands-on training materials.
Develops training resources within functional departments to be able to identify and solve learning needs as they arise. provide Trainer certification, coaching and feedback as well as providing system access and subject matter expertise as necessary
In some cases, will require custom eLearning SCORM files development and delivery(e.g.: Microburst training GxP compliance topics)
Participate in communication feedback activities, including development of training surveys for sign-up and post training effectiveness evaluations
Develop QA guides Support the development of new training objects and exams in the system as assigned
Drive resolution and investigation of any identified training gap and or issue
Provide support for internal and regulatory audits and inspections as required
Introduce new training ideas into the organization, adapts new ideas and converts them into approaches that meet training/regulatory challenges
Perform other duties and responsibilities, as assigned
A minimum of a Bachelor’s degree is required.
Minimum 5 to 8 years’ experience in QA Training management or educational development in a corporate, scientific and/or manufacturing environment within the pharmaceutical, biotechnology industry
Proficient in an electronic Learning Management System (eLMS)
Experience creating and implementing GxP training programs, experience with implementation of eLMS is a plus
Familiarity with training requirements for GxP quality systems, FDA and other Health authority requirements.
Must possess a high level of attention to detail • Strong computer, organizational, and compliance skills
Ability to work effectively on multiple projects simultaneously with minimum supervision
Strong interpersonal and communication skills
Expert level management of training projects with multiple subject matter experts
Experience designing SCORM files required preferably using Captivate Articulate software
Excellent presentation skills and a proven track record of delivering successful training and presentations.
Ability to influence without direct authority.
This job operates in a professional office environment. This role routinely uses standard office equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.
Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
External Company Name: Black Diamond Therapeutics Inc.
External Company URL: www.blackdiamondtherapeutics.com
Street: 139 Main Street