1+ months

Manager, QS Trainer

Baltimore, MD 21202


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Manager, Quality Systems Training is knowledgeable in all aspects of the Emergent Learning Management System (eLM) and process lead for training with implementation of system and process changes. Collaborates with department, site leadership and other Emergent sites to implement a robust and dynamic training program that support Emergent BioSolutions and GMP manufacturing operations. Develop training strategies to aid the Bayview site through the transitions necessary to execute GMP manufacturing operations.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Training/Trainer Support:
Provides training system oversight and planning to ensure personnel are prepared to execute GMP manufacturing needs.
Develops and Delivers interactive presentations on cGxP topics, industry/site trends, and business tools/practices.
Teaches job specific skills using include hands-on demonstrations, lectures, and assessment of trainees' performance.
Designs, deploys, and oversees the site training program and methodology, collaborating with system and process owners to achieve a robust and flexible training system.
Performs gap analyses to identify training areas where training is missing or would be beneficial to improve a process or employee experience.
Assists other members of the training team in learning all capabilities of eLM as well as training technique/processes (i.e., OJT, CBT creation, use of presentation software).
Quality System Ownership / Support:
eLMS System Owner:
o Owns the system and department operations, providing a detailed knowledge of process history, compliance, operations, changes, and non-conformance events.
o Identifies opportunities for improvement; gather user requirements, perform system diagnoses, and collaborate with sites to implement new functionality
o Develop performance metrics and identify the steps necessary to improve performance.
o Present data regarding process performance and system health to site and company Senior Management.
o Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices.
Authors and executes tasks for document revisions, non-conformances, CAPAs, and change controls related to Training department and eLM performance.
Site Support:
Leads Bayview Site Contract Manufacturing Training Development activities
o Lead/Provide the training materials for focused activities for Bayview to ensure that personnel are ready for process changes to support CDMO activities.
o Collaborate with CDMO lead/Project Management as the Quality Assurance liaison to address and coordinate Training deliverables/changes.
Represents the Training department in a review and decision-making capacity on assigned site projects as necessary.
As needed, provides management support and technical knowledge during regulatory and internal inspections.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS degree required or a minimum 7 years related training experience in the pharmaceutical and/or biotech industry or other FDA regulated industry
Experience administering electronic learning management, document management, non-conformance, CAPA, and change control systems.
Must be able to influence without authority across various site departments and with all levels
Previous experience managing rapidly changing cross-functional projects with aggressive timelines.
Strong understanding of regulations governing training and qualification of individuals.
Ability to effectively communicate complex subjects (orally and written) with all levels of employees
High understanding of training procedures and techniques; (i.e. training facilitation, presentation skills, instructional design and curriculum development, adult learning theory and delivery).
Strong working knowledge of Microsoft Office Suite (WORD, Excel, PowerPoint).

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-08-10 Expires: 2023-01-04

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Manager, QS Trainer

Emergent BioSolutions Inc.
Baltimore, MD 21202

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