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. JOB SUMMARY Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices). The role is responsible for (1) QA lead for internal and external projects (2) independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements (3) executing Quality Management System requirements in support of commercial and developmental programs (4) ensuring the realization of industry best practices for GxP and (5) serving as quality approval proxy as requiredThis position is responsible for performing various functions as an owner, reviewer and/or approver. These functions include deviations, change controls, CAPAs, Complaints, Quality Risk Management validation and transfer protocols reports, trend evaluation and reporting, technical review design of history files (and its supporting documentation), review of critical procedures and processes, lead process changes and new product introduction, assist with regulatory responses, and develop and implement process improvements. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Individual will be assigned the responsibility for QA product/client relations and support while working with the client and different teams at the site. Oversight of quality systems as they relate to the multiple product/client and processesIndividual will be liaison between Quality Assurance and other departments to ensure Quality Assurance commitments are completed and to identify areas to improve data trends or process/ product outcomes. They will operate in a cohesive fashionMust be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goalsQuality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination product(s) (devices) at EmergentResponsible for product release, including batch documentation review, management of changes, complaints, deviations, validations, and product annual reviews to ensure completeness, accuracy, and complianceLead or assist in continuous improvement projects as assigned. Interacts with senior leadership, direct manager, peers, departmental or non-departmental personnel, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisionsPerform, review and approve risk assessments and propose risk mitigations and or corrective/preventive actions to reduce process/ product variation as part of the Quality Risk Management programLead Implementation of appropriate CAPA or risk mitigations for Quality related itemsQA oversight of Validation activities including reviewing and approving validation (including Continued Process Verification (CPV)) and stability protocols and reportsQA oversight of product related stability activities including new and routine annual requirementsPerforming review of Design History Files (DHF) for combination products and relevant supporting documentationWrite and implement Quality Plans (where appropriate) to ensure compliance to QMSTrend evaluation and reporting and SPC analysis of trends to determine (when possible) proactive approaches to advert future quality issues with process/ product.Annual product review generation, review and approvalTechnical review and approval of critical SOPs and processesCoordinate and work with Project Managers and Technical Transfer personnel on process changes and new product introductionSupport design and development activities with combination productsQuality oversight of Regulatory Affairs activities including with regulatory submissionsDeveloping and implementing process improvementsOther:Participates in and lead Quality Assurance Process Improvement TeamsParticipates in and lead inspection readiness, audits and regulatory inspections as neededProvide guidance for ISO 13485 and ISO 14971 requirements for combination productsOther assigned responsibilities as established by ManagerSupervisory Responsibilities: No direct reports but routinely act as a QA lead and provide guidance to other departmental personnelRoutinely represents QA management in direct discussions with clients.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, SKILLSBachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred. Minimum 8 years of cGMP experience including Manufacturing and Quality Assurance experience2-3 years in a senior or leadership Quality Assurance roleQualified Person experience preferableBroad 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, European (EudraLex Volume 4) and Health Canada GMPsDemonstrated experience owning, driving and leading Quality initiativesDemonstrated experience working independently with internal and external partnersExperience 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 be a self-starter with ability to work independentlyAbility to manage and deliver multiple priorities, projects and tasks in a dynamic environment using own initiative with little instruction on routine work, general instructions on new assignmentsAbility to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.Ability to lead Change Management activities and strong Project Management knowledgeExcellent communication skills, both written and verbalAbility to exercise judgment to determine appropriate corrective actionsAbility to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutionsAbility to use computer programsThere 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.As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. 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.