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I. Job Summary
The Manager, Document Control and Training, is responsible for ensuring the efficient and effective execution of work within the Document Management and Learning Management systems to support business operations, while remaining compliant with all applicable GxP regulations. The Manager is responsible for these functions at the Camden and MDCW sites.
Ii. Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Direct employees in day-to-day activities relating to the Document Control and Training departments to ensure work is compliant with regulations and standards to support business operations
Local ownership and oversight of the Electronic Document Management System (EDMS) and Learning Management Systems (LMS) including administrator functions
Support of batch record revision process
Ensures effective and engaging GMP training content development and delivery
Performs gap analyses to identify training areas where training is missing or would be beneficial to improve a process or employee experience
Mentors the Training team in learning all capabilities of LMS as well as training technique/processes (i.e., OJT, CBT creation, use of presentation software)
Drive continuous improvements for department processes
Serve as site process owner (SPO) for EDMS, LMS, and associated SOPs, working cross-functionally to ensure changes that impact other departments at the site are identified and mitigated
Identify, monitor, and report to management on key performance metrics supporting the health of department systems/processes
Maintain up-to-date knowledge of industry and regulatory trends to ensure department remains compliant with stated expectations and best practices
Support client and regulatory audits
Support other Quality Systems activities as assigned
Management
All functions associated with recruitment and hiring process for department
Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts
Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group
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
Ensure the team effectively collaborates with key internal and external stakeholders, in accordance with our corporate values and practices
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
Bachelor’s degree in a life sciences or education related field
Experience:
Minimum 5 years creating and delivering educational content to adult learners
Preferred: three (3)+ years’ experience within a regulated manufacturing industry, ideally pharmaceutical or medical device
Preferred: previous people leadership experience
Experience administering electronic learning management and document management systems
Demonstrated 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).
Strong proficiency with MS Office suite
Communication skills: listening, verbal, written, including the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management
Interpersonal skills: conflict resolution, consensus building, leadership, team building
Personal competencies: adaptability, integrity, judgement, self-awareness, vision
IV. PHYSICAL/MENTAL DEMANDS AND 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
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