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.
I: Job Summary
The Quality manager is responsible for independent, QA oversight of each Quality Systems in support of commercial and clinical product manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Manages activities for one or more Quality System or cross functional project.
The Quality Manager will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex technical issues, support quality systems and plant compliance. They partner with third party vendors and customers to ensure effective and compliant outcomes to both Clinical and Commercial GMP-related issues. They apply expertise and regulatory knowledge to support change and risk management, including application of scientific and technical innovation as it pertains to Commercial Manufacturing. The Quality manager develops a lifecycle and systems-based approach to the design and implementation of Commercial Quality Systems and process controls. They recommend solutions to site leadership on cross functional issues. Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decision
Manage QA oversite for quality systems; including investigations, document control, change control, inspections (internal and vendor).
Liaise on occasion between internal Global project team and external customers
Represent the department in interactions with internal functional units and external contract partners or regulatory officials
Manage and Coach employees at various experience levels and provide guidance on compliance and regulations. Provides feedback as needed. Act as advisor to the unit and resolves problems to meet customer needs and scheduled timelines
Create/review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, APR’s, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
Establish, implement and maintain quality management systems to measure and control quality in the production process
Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
Receive assignments in the form of objectives and organizes resources to promote and achieve department goals
Review/support contract negotiations for potential customers (specific to review of sections pertaining to compliance)
Participate in company sponsored training
Lead implementation of strategic plans and support department Operational Excellence Projects
Communicate on Department behalf when needed
Lead key Quality meetings and cross functional teams
Conduct Supplier Audits, as assigned
Develop and revise Quality Technical Agreements as applicable for suppliers providing products or services in support of GMP operations
Manage supplier notification of changes to ensure impact is thoroughly assessed prior to implementation
Liaise with suppliers in addressing nonconformities through thorough investigations. Assess and determine appropriateness of corrective/preventive actions to avoid recurrence
Assist with regulatory and client inspections.
Provide Quality oversite for complex investigations, CAPA’s and changes.
Recognize and promote quality and compliance improvement
Assist with Planning, scheduling and conducting internal inspections per inspection schedule. This includes a review of prior internal inspections and regulatory inspections, reviewing procedures, processes and activities in creating the site Inspection plan.
Help drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems
Conduct regulatory surveillance to maintain current regulatory expectations and devise and provide GXP training to the facility
Facilitates Risk Management process in compliance to appropriate external standards and corporate policies
Apply compliance expertise to support change and risk management, including application of scientific and technical innovation
Develop and lead Product Complaint Program
Develop and lead Product Recall Program
Contribute to management of Annual Product Review
Contribute to the drafting and review of regulatory submissions
Assist with managing Emergent’s Quality Systems including but not limited to Deviations, CAPAs, Change Control, Effectiveness Checks and Management Review in support of manufacturing operations
Lead or participate in cross-functional teams to address facility 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
Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team
Lead/facilitate and support site/Global Quality Council
Manage Employee training assignments/curricula
ID training needs for the direct reports and impacted departments
Lead the development, coordination and presentation of training materials from initial concept to program completion
Lead the development of eLearning utilizing Articulate Software
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.