Sr. Engineer, Supplier Quality

Axogen•Vandalia, OH

1d•Onsite

About The Position

This position reports to the Staff Engineer I, Supplier Quality and is responsible for the implementation, management, and compliance of the GxP Supplier Quality Management (SQM) Program, Supplier Audits, and Quality Agreements. This role ensures a robust and compliant SQM process that complies with FDA, EMA, Health Canada, ISO, and other applicable regulatory requirements and company procedures. The position is responsible for executing the SQM strategy and facilitating SQM integration with cross- functional processes. The role will also provide Quality Assurance support and oversight to contract service provider selection and qualification processes.

Requirements

Bachelor's degree in the sciences (biology, chemistry, biochemistry, or chemical engineering) with 5+ years of pharmaceutical or biopharmaceutical experience in a GMP environment.
Experienced auditor with minimum 2 years auditing in pharmaceutical or medical device industry.
Working experience managing a supplier quality management program.
Demonstrated understanding of Quality principles, industry practices, and standards (21 CFR, ISO, GxP, ICH, etc.) and ability to apply these to GxP operations internally and contract service providers.
Experience with commercial drug product operations including biologics, finished goods production, API and excipient manufacturing, and analytical testing.
Independent decision making with a high degree of initiative.
Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
Motivated self-starter; detail and results-oriented.
Well organized and efficient with ability to manage multiple priorities.
Innovative thinker and problem solver

Nice To Haves

Quality auditor certification is preferred.
Combination product or medical device experience is a plus.

Responsibilities

Manage the Supplier Quality Management Program for company contract service providers (CSPs) including the following:
Oversee the GMP Supplier Audit Program - Lead supplier audits, coordinate auditor assignments, and manage audit schedule, agendas, responses, reports, statuses, and audit closures.
Create, revise, approve, and maintain the Supplier Quality Agreements.
Maintain the Approved Supplier List and supplier qualification statuses.
Collaborate with Subject Matter Experts to support supplier selection.
Organize, archive, and maintain Supplier Audit Files and establish KPls and SQM metrics.
Report on supplier performance to Quality management.
Represent SQM in external and internal audits, and on cross-functional teams and initiatives.
Train personnel on the SQM program.
Supports change management by authoring impact assessments for changes to CSP services.
Proactively evaluate systems and processes to identify improvements with a focus to simplify and standardize.
Lead and drive improvements as required.
Revise and approve standard operating procedures and other controlled documents as necessary.
Supports regulatory inspections and inspection readiness activities.