Manager, Quality Assurance

Company: Emergent BioSolutions Inc
Location: San Diego
Posted on: February 23, 2021

Job Description:

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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. Position Summary The Manager QA will be responsible for providing quality leadership and oversight to VaxBU projects and programs supporting the clinical lifecycle development of investigational clinical supplies. In this role, the Manager QA, will be responsible for independent oversight and support of GxP operations supporting Emergent Travel Health product development, manufacturing and testing activities, both on site and at contract manufacturing organizations. The Manager QA will assist with development of strategies for projects and programs. Will effectively apply phase appropriate quality systems approach and lead the organization in compliance. Essential Functions -- Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Responsible for Quality oversight of GxP activities related to the manufacturing and testing of early phase development products. Provides cGMP phase appropriate QA oversight and application for Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release and Change Control initiations, reviews or approvals.
• Authors, reviews and approves, as necessary, Standard Operating Procedures, analytical test methods, batch records, specifications, protocols, technical transfer packages and other documentation used in the development, manufacturing, packaging, testing and distribution of product.
• Provides quality oversight, review, and approval of analytical method validation.
• Serves as an independent Quality Assurance lead to assigned projects from initiation through targeted completion: provide quality and compliance input, assess and evaluate risks, serve as a Core Team member for the respective function, adheres to planned timelines, identifies project critical attributes and proposes remediation strategy
• Supports external audits as required
• Challenges current procedures and practices to afford optimization and further development of existing quality standards and overall compliance.
• Represents Quality Assurance and Emergent during FDA and other regulatory agency in
• Strong quality and analytical technical background in the biologics
• Demonstrate initiative and accountability in a fast-paced environment with minimal supervision on multiple projects
• Strong hands on knowledge and ability to identify and/or independently resolve complex quality issues with other functions in a proactive, diplomatic, flexible and constructive manner
• Mentors employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
• Conducts personnel interviews and provide feedback to group.
• Identifies opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable.
• Mentors, coaches, challenges and develops team members while serving as a role model of Emergent's core values.
• Ensures the team effectively collaborates with key internal and external stakeholders, including manufacturing, regulatory affairs, analytical development, supply chain and IT Minimum Education, Experience and Skills
  • Bachelor Degree in Biological Science or similar science
  • Minimum of 10 years of pharmaceutical cGMP Quality experience with increasing responsibilities and GMP knowledge.
  • Previous experience working with FDA (CBER) and participating in regulatory agency inspections
  • Must have a full competence of cGMPs, 21CFR210, 211, 600, USP, and Aseptic Processing Guidelines.
  • Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content and criticality of information.
  • Must have personnel management skills and good written and verbal communication skills. The ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups.
  • Experience in vaccines development and manufacturing is a plus.
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required 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. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
    • Stand shoulder to shoulder no matter what
      • We combine our best thinking and communicate openly to support each other.
      • Break through thinking
        • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
        • Own it always
          • Every person at Emergent is engaged and accountable for delivering on our commitments.
          • Compete where it counts
            • We set the right goals and respect each other as we conquer them together.

Keywords: Emergent BioSolutions Inc, San Diego , Manager, Quality Assurance, Professions , San Diego, California