Manager, Quality Assurance
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 QA Manager is responsible for quality oversight of GMP manufacturing and/or testing at the Emergent Rockville site, timely release of product and provides quality oversight of Quality System work primarily direction on deviation investigations. Acts as system owner for Batch Release, Batch Review, Complaints and other Quality Systems. Coaches employees and drives development of employees, schedules and manages workloads for direct reports. Responsible for interaction with Regulatory officials during inspections. Approver of key quality systems documentation related to areas of responsibility.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Ensures adequacy of deviation investigations by serving as a final approver on Major/Critical Investigations.
- Ensures sufficient root cause analysis and adequate corrective and preventive actions are taken in response to quality issues.
- Manages workload in the quality systems.
- Ensures adequate day to day oversight of CMO activities.
- All functions associated with recruitment and hiring process for Rockville Quality Assurance positions (full-time, part-time, temp, limited term)
- Develops and maintains resource models for department staffing
- Prioritizes activities and responsibilities for direct reports to ensure continued support of projects, manufacturing operations and customer commitments. Develops and administer schedules and performance requirements Coaches employees and drives continuous improvement efforts related to the areas of responsibility.
- Represents Quality Assurance and Emergent during FDA and other regulatory agency inspections.
- Represents Quality Assurance and Emergent for customer relation activities with CDC, BARDA, DoD and HHS.
- Provides high level FDA, EMA, and ICH guidance and other regulatory expertise to support project teams in maintaining required compliance and to provide awareness and preparation for agency inspections.
- Ensures timely release of products and materials while maintaining compliance with and helping interpret appropriate Current Good Manufacturing Practice (CGMP) regulations. Provides oversight of Quality Assurance department and quality systems including Batch Record Review and Product Release, which includes:
- Exercises sound quality judgment to ensure that final product release is executed in accordance with regulations and CGMPs. Provide oversight and final disposition of product for distribution Interacts with senior management in order to update management about quality issues requiring elevation and recommendations for resolution of those issues. Works collaboratively across to functional areas to develop mutual solutions for quality and operational issues that are both compliant and representative of sound business practice.
- Prepares Governance Committee, Management Review and Corporate Management Review Batch Release metrics. Conduct analysis of identified trends and propose/ implement necessary corrections to address identified trends.
- Acts as the Quality Assurance approver of Batch Production Records, SOP revisions, validation & technical study protocols.
- Acts as the Quality Assurance approver lot release protocols for submission to Regulators.
Providing guidance to subordinates to achieve goals in accordance with established policies, cost and schedule guidelines. Acting as advisor to subordinate(s) to meet schedules and/or resolve technical problems
- Provides ownership and oversight of one or more of the following systems: Deviation, Batch Release, Product Inquiry, and/or Complaint system(s).
- Represents Quality Assurance and Emergent during FDA and other regulatory agency inspections
- Acts as the Quality Assurance approver of Deviation Investigations, SOP revisions, LIMS Change Requests, Validation documents (protocols, reports, assessments, etc.)
- Supports the Quality Assurance team during deviation / formal investigations, including participation in root cause analysis activities, document review and verification, determination of corrective / preventive action and assessment of product impact.
- Participates as Quality Assurance representative on various project teams with impact to compliance and/or the Quality Systems.
*Requires vaccination against different viruses including Vaccinia virus.
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
- 5-7 years of experience working in an FDA regulated industry including participation in agency inspections. Experience with non-US regulators preferred.
- Minimum of five (5) years of experience working in Quality Assurance
- Previous experience operating within Quality Systems such as: Deviation, CAPA and Change Control
- Requires a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, and investigate complex deviations.
- Experience with aseptic processes preferred. Gowning for BSL-2 and BSL-3 environments preferred.
- Candidate must exhibit strong interpersonal, oral, written and communication skills.
- Ability to work independently and in a team setting with minimal supervision
- Ability to make sound decisions regarding compliance-related issues with minimal supervision.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
Minimal travel to other sites. May include international travel to support project needs.
Requires vaccination against different viruses including Vaccinia virus.
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.