Training Manager

2 weeks ago

Raleigh, United States Indivior PLC Full time
TITLE:
Training Manager

Title: Training Manager

Reports To: Head, Site Quality, Raleigh

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

This role is responsible for designing and delivering GMP, technical, and organizational development training (both classroom training and e-learning), along with assisting functional areas with developing competency-based training for the Raleigh site. Training will occur in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance, and management development in a GMP aseptic environment and testing laboratories.

This individual will also liaise with Global Quality Systems and OPEX to assist in the development of organizational strategies and training programs/processes to enhance organizational effectiveness, including interacting with personnel from other sites, as needed.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:
  • Develop, maintain and trend the performance of the site training program in conjunction with the global training process and procedures.
  • Assess and identify training needs at the site through observation and communication with employees and management.
  • Create, revise, and manage site program content, instructional tools, and hands on exercises, including computer-based training.
  • Confirm the effectiveness of training through testing, observation, and analysis of downtime and deviation records.
  • Develop and maintain competency and skills matrices.
  • Function as the site LMS SuperUser, entering data and supporting LMS activities for the site as required.
  • Work and communicate with the Global Quality System and OPEX team relating to the global training process to ensure alignment.
  • Provide expertise in site training and evaluation of trainers' skills, including classroom trainers and OJT trainers.
  • Develop, implement, and maintain training schedules based on departmental workloads and information such as SOP issuance and curricula assignment.
  • Monitor and manage employee training records and qualification status as required.
  • Participate in audits and inspections serving as the training subject matter expert specific to the site.
  • Knowledge and understanding of regulatory requirements such as 21CFR part 210 and 211, 820, Annex 1, cGMPs, FDA, TGA, HPRA, MHRA, OSHA and other regulatory agencies.
  • Transfer knowledge of training and learning methodologies to build a culture of learning and development.
MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel: Approximately 10% travel.
  • Minimum of a Bachelor's Degree in a relevant field of study, as well as proven experience in a role developing and implementing training plans.
  • 10+ years working in pharmaceutical manufacturing or related GMP industry.
  • 5+ years developing, delivering, and assessing classroom, computer-based, and competency based functional training in a GMP environment.
  • Proven needs analysis, instructional design, monitoring, and classroom training skills.
  • Experience developing, delivering and assessing training in one-on-one and classroom setting.
  • Excellent organizational and multitasking capabilities and ability to work cross functionally across all levels of the organization.
COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:
  • Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.
BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
  • 3 weeks' vacation plus floating holidays and sick leave
  • 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
  • U.S. Employee Stock Purchase Plan- 15% Discount
  • Comprehensive Medical, Dental, Vision, Life and Disability coverage
  • Health and Dependent Care Flex Spending options
  • Adoption assistance
  • Tuition reimbursement
  • Leverage Concierge/personal assistance services
  • Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
  • Gym, fitness facility and cell phone discounts
  • Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.


GUIDING PRINCIPLES:

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled

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