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I. JOB SUMMARY

The Specialist II, Quality & Regulatory Compliance, is responsible for representing Emergent in all aspects of regulatory inspections, regulatory submissions (i.e., INDs, CMCs, GMP Renewals), legalized documents, state licenses, regulatory certificates and licenses internal and customer audits; including but not limited to hosting audits, inspection preparation and logistics; as well as preparing written responses, ensuring completion of all audit-related corrective actions.

Responsible for updating the Site Master File (SMF), drafting, and revising Annual Product Reviews (APRs), Quality Agreements, and supporting the update of the Drug Master File (DMF) as needed. This position will also maintain the regulatory surveillance program. This position is responsible for cGxP compliance (and all other applicable regulations) and supporting activities relating to these systems at the Camden site.

Keep abreast of changes to quality regulations and guidelines, advising management of any business implications of these changes and assessment of any gaps identified.

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

General Compliance and Regulatory
• Maintain an understanding of current industry regulations, guidelines, and standards as well as regulator activity and current trends in 483’s, warning letters or other recent regulatory actions. Ensure this information is communicated to the site and is translated into the current systems and processes.
• Represent Quality Assurance and Emergent during FDA, EU, Health Canada, and other regulatory agency inspections and customer relation activities.
• Complete inspection response reports, monthly response updates and coordinated response owner teams as well as regulatory gap analysis activities.
• Performs final Quality Assurance approval of documentation for regulatory submissions (e.g., BPDR’s, CMC, DMF, and related correspondence).

General Quality Systems:
• Serve as reviewer and approver of documents ensuring data integrity and traceability, clarity of technical writing, compliance with SOP’s/regulations and suitability for review by regulatory authorities.
• Define, prepare, and communicate metrics, trends, and data summaries to management, as needed.
• Work across all disciplines and functional areas to ensure that the site maintains a state of inspection readiness.
• Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as appropriate.
• Keep abreast of changes to quality regulations and guidelines, advising management of any business implications of these changes.

The following activities are focus areas, that may be a primary or a backup responsibility:
Regulatory Surveillance Coordination:
• Analyze multiple documents, records, and findings, as well as interview personnel, to determine compliance to cGxP regulations. Strong judgment, critical analysis, critical thinking skills required. Ability to assess strengths and gaps of systems and processes.
• Must be able to multi-task, self-manage your time, consolidate, and analyze multiple documents simultaneously.
• Follow up with area management on audit responses and corrective actions. Provide support as needed to clarify root cause analysis and appropriate corrective actions.
• Serve as System owner for Regulatory Surveillance system; responsible for system effectiveness, propose and implement continuous improvements and provide system trending information.

Internal Audit / Regulatory Inspection Coordination as required:
• Develop internal and (possibly external) audit schedules for upcoming year. Write and distribute audit plans and reports. Conduct Internal and external audits (as applicable), according to the established schedule, with minimal oversight. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan.
• Communicate audit results to audited areas and Management.
• As the Host and coordinator for Regulatory audits and inspections- oversee day to day audit / inspection activities, communicate status/findings and coordinate all necessary resources, throughout the audit / inspection.
• Analyze multiple, documents, records, and findings, as well as interview personnel, to determine compliance to cGxP regulations. Strong judgment, critical analysis, critical thinking skills required. Ability to assess strengths and gaps of systems and processes.
• Draft and submit written responses to any audit / regulatory findings.
• Follow up with area management on audit / inspection responses and corrective actions. Provide support as needed to clarify root cause analysis and appropriate corrective actions.
• Effectively negotiate difficult conversations on a routine basis.
• Verify corrective action effectiveness in accordance with regulatory expectations.

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 Biological Science or similar scientific field and 5+ years of experience, or 9+ years of experience in lieu of Bachelor's degree
• Minimum of 8 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities
• 5-8 years prior experience conducting quality audits.
• Previous experience working with FDA (CBER) and participating in regulatory agency inspections desired.
• Must have a full understanding and knowledge of cGMPs and EU Regulations.
• Must have Change Control, SOP, investigation, and protocol writing skills and demonstrated ability to critically evaluate content and criticality of information.
• Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for internal and external review.
• Proficiency in MS Office products, SAP or comparable word-processing and spreadsheet skills are required.
• Able to work flexible hours to facilitate needs and requirements as required.

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.