Analyst III, Global Quality Systems
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.
The Emergent BioSolutions Global Quality Systems Analyst III will support the execution and deliverables associated with the harmonization of our Global Quality Management System across the enterprise. More specifically, this Analyst III will lead in the development and maintenance of the Regulatory trace matrix, partnering with the Global Process Owners to ensure the regulations and standards are reflected within the matrix. This role will also partner with Quality IT in the development of an automated solution to manage these requirements long term. This role will lead projects and collaborate with other team members in the development of tools, methods and processes for governing a globally harmonized Quality Management System.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Develop and Maintain a Quality System Regulatory Trace Matrix and associated training materials
• Collaborate with Global Process Owners to teach and ensure Regulatory Trace Matrix is updated and accurate
• Map Emergent Global QS Standards to Regulations
• Partner with QA IT to develop the requirements and implement IT solution to manage Regulatory Trace Matrix
• Lead and manage the global process owners through assessment and remediation of the Quality System as it pertains to New and changing Regulations, Standards and Globally Harmonized procedures
• Develop and maintain tools for Global Harmonization (i.e. QMS gap assessment tool, Checklists, process assessments etc…)
• May perform site process assessment to ensure effectiveness of global deployments
• Collaborate with Document Control to develop process area reports for Global Process Owners
• Lead and manage Global projects, CAPA’s and Deviations as needed
• Lead or participate in cross-functional teams to address global issues using methodical problem solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
• Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s Degree preferred or applicable relevant work experience is acceptable, in place of degree
- A minimum of five (5) years of cGMP Quality experience
- Prior experience with pharmaceutical or medical device regulations and ISO standards
- Knowledge and application of GMP principles, and working in an FDA regulated environment
- Strong communication skills: oral/written and listening
- Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
- Interpersonal skills: team building, consensus building, conflict resolution
- Critical analytical skills, strong verbal and communication skills
- Ability to work independently within scheduled timeframes
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
- Good presentation skills, including written and verbal communication skills
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.
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.