Quality Assurance Manager, Biopharma (JP10285)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Quality Assurance Manager, Biopharma (JP10285)
Location: Thousand Oaks, CA Employment Type: Contract Business
Unit: Combination Products Operations Quality Control Duration: 6
months with likely extensions Posting Date: 05/20/22 3 Key
Consulting is hiring a Quality Assurance Manager for a consulting
engagement with our direct client, a leading global
biopharmaceutical company. Job Description: 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. Responsibilities: 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. 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 with
regard to 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. Preferred Qualifications: Why is the Position
Open? Supplement additional workload on team. Top Must-Have Skill
Sets: Process Improvement Strong critical thinking, problem
solving, risk assessment, and risk management skills. BS in
Engineering, with experience in Quality Assurance experience (2)
Medical device and/or pharmaceutical industries background, a plus
not requirement 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 Day to Day Responsibilities: Work
with cross functional areas to achieve timelines for projects,
method development, CAPAs, deviations, change control and others;
in alignment with our SOPs and regulatory expectations. Red Flags:
No quality experience Engineering background/degree or engineering
experience, preference is Engineering degree Interview process:
Phone screening followed by in-person interview. We invite
qualified candidates to send your resume to
resumes@3keyconsulting.com . If you decide that you’re not
interested in pursuing this particular position, please feel free
to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Lompoc , Quality Assurance Manager, Biopharma (JP10285), Science, Research & Development , Thousand Oaks, California
