Manager, Quality Assurance
Company: Emergent BioSolutions Inc
Location: San Diego
Posted on: February 23, 2021
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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
- 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
- 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
- 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
- Conducts personnel interviews and provide feedback to
- 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
- 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
-- 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
- 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
Keywords: Emergent BioSolutions Inc, San Diego , Manager, Quality Assurance, Professions , San Diego, California
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