Job Title:   Quality Assurance Manager - (JP9589)
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: 12/28/21
Notes:  Remote pending lift of COVID restrictions

3 Key Consulting is hiring a Risk Management Senior Associate 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 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.

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 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.