Manager, Quality Training

Location: 

Rockville, MD, US, 20850

 

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.

I. JOB SUMMARY

The Manager, QA Training will foster psychologically safe and inclusive space to encourage a strong collaborative work environment across the Emergent enterprise.  This manager is responsible for maintaining a modern and cGMP compliant Training program, ensuring general cGMP training is aligned with global quality system standards, and enabling and supporting functional units to establish functional training programs sited to their functional structure and the associated activities executed within their function. This manager maintains current knowledge of industry training trends and adult learning philosophies to support the continual improvement of the quality training program and provide guidance to functional leaders to support the evolution of functional training programs. This manager coordinates the facilitation of general GMP training to new employees along with periodic refreshers to meet compliance requirements.  This manager represents the general training program in regulatory inspections and site audits as well as supporting general audit and inspection activities, as needed.

 

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.
  • 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 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.

 

III.MINIMUM EDUCATION, EXPERIENCE, SKILLS

 

  • The completion of a Bachelor of Science degree, accompanied by over 10 years of job-related experience, or an equivalent combination of education and experience.
  • Certification in Adult Education with 5 or more years of relevant experience directly within a regulated space, preferably Pharma or Biotech delivering adult training, a portion of which must be technical and/or pharma related.
  • Minimum of 3 years of people management experience
  • 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).

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 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

  • 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.


Nearest Major Market: Washington DC