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Manager, Quality Assurance

Location: 

San Diego, CA, US, 92121


 

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.

 

Positioni Summary

The Manager QA will be responsible for independent oversight and support of GxP operations supporting Emergent Travel Health product development, manufacturing, testing and release activities, both on site and at a contract manufacturing organization.

This role will also provide support to equipment and method qualification activities relevant to the manufacturing.

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.

This position will interact with area team leads, supervisors, other cross functional peers and CMOs.

 

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 as well as assist in any investigations in response to deviation, complaints, OOS and/or OOT.
  • 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 equipment qualification and analytical method validation.
  • Review executed batch records, test results and support in batch release activities.
  • Acts as an independent Quality Assurance lead for assigned projects from initiation through targeted completion with minimal supervision.
  • Provides 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 internal and 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 inspections

Management/Competencies

  • Strong quality background in the biologics
  • Demonstrate initiative and accountability in a fast-paced environment with minimal supervision on multiple projects
  • Mentors and develops team members while serving as a role model for Emergent’s core values.
  • Identifies opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable.
  • Ensures the team effectively collaborates with key internal and external stakeholders, including manufacturing, regulatory affairs, analytical development, supply chain and IT

 

Minimum Education, Experience, Skills

  • Bachelor’s Degree in Biological Science or similar science
  • Minimum of 7-10 years of QC/QA cGMP Quality experience with increasing responsibilities.
  • Knowledge of 21CFR210, 211, 600, USP, and Aseptic Processing Guidelines. 
  • Must have strong knowledge of controlled document lifecycle and attention to detail.
  • Must have strong interpersonal and communication skills and excellent written and verbal 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.


Nearest Major Market: San Diego