Manager, QA Doc Control

3 months ago

Baltimore, Maryland, United States Emergent BioSolutions Full time

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, 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:

o Minimum 5 years creating and delivering educational content to adult learners

o Preferred: three (3)+ years' experience within a regulated manufacturing industry, ideally pharmaceutical or medical device

o 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.

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