Specialist II, External Quality Operations

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

Reporting to the Director, External Quality Operations, the External Quality Operations Specialist supports the efficient operation and management of the External Quality organization by supporting quality process standardization, harmonization, maintenance, and continuous improvement, tracking and reporting on risks, managing metrics definition, analysis, and reporting.

The External Quality Operations Specialist will collaborate across the organization to achieve uniformity and consistency in quality systems within the External Supply organization while promoting Emergent’s core values and accountabilities.

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

The External Quality Operations Specialist is responsible for:
• Execution of standardization, harmonization, and continuous improvement objectives of External Quality processes.
• Coordinating and leading cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
• Ensuring External Quality processes and procedures align to Emergent global standards and applicable regulatory requirements for the associated product portfolio.
• Working collaboratively with partners and stakeholders to ensure quality processes support business objectives and interrelated processes.
• Development of harmonized External Quality training curricula in conjunction with the Emergent Global Training Center of Excellence.
• Leading quality system changes to ensure sustained compliance with new or revised regulatory requirements and external standards.
• Leading the implementation of Quality Management System improvements in collaboration with key stakeholders to achieve strategic Quality priorities.
• Conducting training for revised QMS processes within and across the External Quality organization.
• Coordinating, scheduling and facilitating the identification, gathering, analysis and reporting of Quality System performance and quality risk management metrics via the Quality Management Review process, including in-depth analysis of metrics.
• Identification, assessment, communication, management, and mitigation of quality management system risks.
• Support GxP audits and inspections and supplier quality management processes for External Quality.
• Provide support, as assigned, to M&A diligence activities and to quality integration of acquired assets including transfer of quality records, assessment, planning, and execution of quality systems alignment (when/where necessary), product and process knowledge transfer to responsible quality authority, initial set up of quality oversight model for external manufacturing partners and supply chain.

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
• BA/BS (preferably in an Applied Science) or equivalent work experience.
• Minimum 6 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Medical Device Manufacturing and previous Quality Assurance experience.
• 2-3 years of project management experience or leadership role within medical device regulated industry preferred.
• Broad experience and thorough understanding of international GMP Quality Management System regulations for drugs and devices including ICH Guidelines, ISO 13485, FDA 21 CFR Parts 210, 211 and 820, EU and Health Canada GMPs including EU MDR.
• Strong experience with quality systems development, management, and improvement.
• Demonstrated experience with facilitation of workshops related to QMS transformation.
• Experience as process owner for deviation, CAPA, change management, and self-inspection programs as well as managing 3rd party audits and inspections is preferable. Experience with quality risk management will be considered an asset.
• Must have ability to work independently.
• Ability to manage multiple priorities, projects and tasks in a dynamic environment.
• Excellent communication skills, both written and verbal.
• Ability to exercise judgment to determine appropriate corrective actions
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
• Ability to use computer programs

**This position is fully remote

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 [Register to View] .

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.