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Manager, GPO Quality Training

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
May 17, 2024

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Discipline
Administration, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital, Best Places to Work

Job Details

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I: JOB SUMMARY 
The Manager, Global QS Training will foster psychologically safe and inclusive space to encourage a strong collaborative work environment.  

They are responsible for maintaining a modern and cGXP compliant Training program, ensuring training processes executed across the network maintain alignment and standardized general cGXP training is delivered in a consistent manner across the enterprise.  This individual works closely with Document Control functions to assure seamless integration of DocCon and training processes for efficiency and compliance.  

This manager maintains current knowledge of industry training trends and adult learning philosophies to support the continual improvement of the quality training program.  They are responsible for direct management and development of training program managers for multiple sites across the Emergent network.   They provide guidance to the QS Training team to support functional leaders across the organization in the evolution of functional training programs. 

This individual serves as the Global Process Owner (GPO) for Emergent GxP Training programs, provides leadership to other QS processes such as Document Control and represents global QS programs in regulatory inspections and site audits. 

 

II: ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Lifecycle Maintenance of Training Program - Participating in global governance community for Global Quality Training Program, bringing subject matter expertise to represent site or process specific issues and solutions to drive continuous improvement to Training Program effectiveness and efficiencies. Soliciting input from stakeholders related to process improvement.
•    Supervises daily operations of the Quality Training staff, providing support and prioritization as needed. 
•    Collaborates with cross-site Quality training leads to support global training material library and share technical capability and compliance training to providing consistent and compliant trainings to meet organizational needs.
•    Partner with functional unit leads, SMEs, and project managers across the organization to understand training needs and recommend training approaches and solutions. 
•    Supports functional units by reviewing training programs and observing delivery by functional/SME trainers, as necessary. 
•    Act as the business owner for Success Factors ELM learning management platform
•    Support the identification of training KPIs associated with the effectiveness, efficiency and general internal compliance to training programs. 
•    Monitor, analyze, and report metrics for program performance, cross-functionally collaborating on appropriate actions where opportunities or risks are identified. 
•    Participate in recruitment, hiring, and retention of Training personnel, providing mentorship and guidance to support overall performance excellence and career development.
•    Propose and justify departmental budgetary requests and oversee activity execution to maintain adherence to departmental budgets.
•    Review Document and Process change controls to assess impact to existing training plans and audiences.
•    Works with process owners to build help strategically design training programs to support corresponding processes.
•    Ensure appropriate record retention in compliance with all regulatory and internal record retention requirements.  
•    Review and approve unit training programs and ensure that they comply with GXP requirements and internal standards. Manage and participate in internal and external/regulatory audits and corrective actions/responses.

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
Minimum Requirements
To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

•    The completion of a Bachelor’s degree, accompanied by over 10 years of job related experience, or an equivalent combination of education and experience.
•    Certification in Adult Education is preferred or equivalent direct applicable experience in a regulated environment.
•    Minimum of 5 years in GxP – pharmaceutical, biotech, or med device industry. 
•    Minimum of 3 years in management (people or projects)
•    Demonstrated excellence in cross-functional team leadership and collaboration
•    Experience with electronic document management, non-conformance, CAPA, and change control systems.
•    Knowledgeable in GxP regulations governing training and qualification of individuals.
•    Ability to effectively communicate (orally and written). 
•    High understanding of training procedures and techniques; (i.e. needs assessment, training facilitation, presentation skills, instructional design and curriculum development, adult learning theory and delivery, evaluation of training).

 

IV: PHYSICAL/MENTAL DEMANDS WORK ENVIRONMENT CHARACTERISTICS

 

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.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Company info
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
US

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