Quality Assurance Manager, Biopharma (JP9806)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Quality Assurance Manager, Biopharma (JP9806)
Location: Thousand Oaks, CA. or Cambridge Employment Type: Contract
Business Unit: Final Product Technology Quality Duration: 1 years
(with likely extensions and/or conversion to permanent) Posting
Date: 2/10/2022 Notes: Remote pending lift of COVID restrictions 3
Key Consulting is hiring a Quality Assurance Manager for a
consulting engagement with our direct client, a leading global
biopharmaceutical company. Job Description: These roles will start
out remote due to COVID and then will go to onsite, M-F. Can sit in
Thousand Oaks or Cambridge. Provide quality oversight with regards
to the development and lifecycle management of test and inspection
methods and fulfillment of regulatory commitments. Potential scope
of products with regards to test and inspection methods includes a
wide range of devices, raw material components, and constituent
parts, such as: needle protection systems, fluid transfer devices,
pen injectors, automatic pen injectors, and micro-infuser delivery
pump systems. The qualified candidate will both lead and/or support
technical teams to ensure successful method development or
remediation and/or fulfillment of regulatory commitments. The role
of the Senior Quality Engineer is to provide quality oversight to
one or more cross-functional teams to utilize technologies and
methodologies that support short-cycle robust development,
accelerated compliance efforts, and/or remediation/improvement
opportunities. Work cross-functionally and globally with
individuals and project teams within Final Product Technologies
Quality and the Final Product Technologies Engineering groups and
their stakeholders in Marketing, Operations, and Development;
Ensure compliance to design controls and fulfillment of user needs
during test or inspection method development or design changes,
including proper and compliant integration of different subsystems
as required. – Provide quality oversight and guidance regarding the
development of process control plans and implementation of process
improvements/changes. – Work with cross-functional teams to
develop, qualify, and transfer physical test or inspection methods.
- Provide comprehensive quality guidance and advice to counterparts
and stakeholders. Why is the Position Open? Supplement additional
workload on team. Top Must Have Skills: Quality Assurance
experience. Experience with technical methods. Experience with
combination products. Day to Day Responsibilities: Review and
approve FP Mechanical/Physical methods, method development reports,
user requirements, method validation reports and method transfer
reports. Provide oversight to ensure accuracy and precision of
methods to measure final product specifications. Review material
characterization data, work with Regulatory to inform teams of any
regulatory requirements that must be met. Facilitate PAI readiness
for notified bodies and act as escort. Review method transfers
across sites and suppliers to provide quality perspective and
approval. Provides advice to regulatory on submission strategies
associated with platforms and physical methods. Inform other
Quality functions of any material requirements. Provide quality
expertise and technical knowledge to Final Product Key External
Initiative (KEI). Co-develop training materials for method
transfers and stability method transfers with FPT Core
Technologies. Co-develop training materials for stability method
transfers with FPT Core Technologies Basic Qualifications: BS or BE
in Engineering and previous experience in the medical device and/or
pharmaceutical industries. 8 years current experience with
engineering processes/procedures and quality tools. Major
contributions to or the leadership of projects from development
through the 510k and PMA approval process. Experience with material
& test specs generation, protocol & report writing, process & test
development, prototyping, design verification/validation, DOE/SPC
process optimization & validation (IQ, OQ, PQ), P/DFMEA. Product
design/development (design control) from concept to post product
launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in test or inspection method design and development.
Small scale device assembly and/or benchtop testing experience.
Experience with Automated Test Equipment (ATE). Experience
regarding Measurement Systems Analysis/GRR principles, including
study design/execution/troubleshooting. Strong critical thinking,
problem solving, risk assessment, and risk management skills. Must
be capable of working on multiple projects in a deadline driven
environment. Employee Value Proposition: Working at a great
biotech/pharma company, working with a dynamic team on challenging
concepts, growing your skill set in the role. Red Flags: No and or
minimum QA experience. Interview process: Video Skype Panel
Interview We invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to look at
the other positions on our website
https://3kc.catsone.com/careers/2010-General. You are welcome to
also share this opportunity with anyone you think might be
interested in applying for this role. Regards, 3KC Talent
Acquisition Team
Keywords: 3 Key Consulting, Santa Clarita , Quality Assurance Manager, Biopharma (JP9806), Science, Research & Development , Thousand Oaks, California
