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Manager, Global Quality Systems Training

Location: 

Gaithersburg, MD, US, 20879


 

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.

Emergent BioSolutions Global Quality Systems Training Manager will lead in the development, design, harmonization and deployment of the Quality Training Processes across the global network in order to maximize efficiency, effectiveness and compliance while enabling a culture of quality across the enterprise. This role will also partner with all Global Quality System Process Owners in developing the global training strategies and content across the QMS.  They will also work cross functionally with Human Resources to maintain and improve the capability of the electronic Learning Management (eLM) System. This role will lead a team of both direct and indirect subject matter experts in this harmonization effort.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Quality Systems 
•    Assist in the development and governance of our Global Quality Management System, including process harmonization, governance, management oversight.
•    Identify, prioritize, and oversee quality improvement efforts with a goal of continually improving efficiency, effectiveness, and compliance with applicable cGMP regulations. This may also include leading system / process engineering or redesign efforts, as required.
•    Participate in the development of global quality training objectives (e.g., annual improvement priorities), ensuring that Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.
•    Provide regular updates and KPI’s for Global Quality Management Review as reflected in the annual Global Quality Plan 
•    Support the Deviation, CAPA and Change Control systems, ensuring clear root causes are identified and addressed with robust, and where appropriate, global actions to prevent occurrence or reoccurrence of the event, and ensuring that actions are assessed for effectiveness post-implementation.
Training 
•    Leads a Training Process Community in the harmonization of our training processes,  systems and tools.  
•    Serve as the Training Global Process Owner and leader of the Training Process Community in continual improvement activities.
•    Works with key stakeholders and uses Instructional Design principles to build harmonized global curricula that maintain and enhance compliance. 
•    Work with system stakeholders to ensure user requirements are met and improvements are implemented to increase user satisfaction, system usability and compliance. 
•    Establish global performance metrics and work with sites to develop, implement, and sustain performance improvement strategies.
•    Oversee and participate in the design and development of role-based instruction for computer-based courses, workshops, classroom training, virtual webinars, etc.
•    Ensure procedural alignment across the Training and Document Control processes
•    Ensure alignment and partnership between the training and document control teams
Management
•    Define a global training support model and service levels 
•    All functions associated with recruitment and hiring process for EBSI Global Quality Systems positions.
•    Lead and manage both direct and indirect staff.
•    Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
•    Conduct all aspects of the performance management cycle: personnel interviews, annual goal planning, performance reviews, development plans and ongoing mgmt. of personnel.
•    Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable. 
•    Mentor, coach, challenge and develop team members while serving as a role model of Emergent’s core values. 
•    Demonstrates effective leadership behaviors in accordance with Emergent’s core values, accomplishing objectives while instilling trust, engagement and collaboration among colleagues and team members. 
•    Plan and track all budgetary requirements.  Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel. 
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 management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree 
•    A minimum of five (5) years of life sciences/cGMP experience and five (5) years’ experience within Quality.
•    Complex analysis of business impacts/scenarios, including risk management, financial analysis (e.g. ROI, Cost of Quality).
•    Strong communication skills: oral/written and listening
•    Experience with electronic Learning Management Systems, training practices and principles, non-conformance, and change control systems
•    Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
•    Interpersonal skills: leadership, team building, consensus building, conflict resolution
•    Previous experience in management of quality systems and Quality department. Highly desirable to have minimum of 5 years of supervision experience. 
•    Must have personnel management skills and good written and verbal communication skills.  The ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management and executive management.  
•    Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
•    Experience in organizational design and organizational change management is highly desirable.
 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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 actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

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


Nearest Major Market: Washington DC