Quality Auditor II

Job Description

Note:  

• Some Travel (Up to 20% (primarily to Indiana CMO site).
• The position is fully remote with periodic travel to the CMO.
• Travel to the Indiana manufacturing site as needed, especially during onboarding and initial phases.
• No international travel is expected.

Position Overview: 

• The Quality Auditor II will provide quality oversight for an aseptic medical device product manufactured at a Contract Manufacturing Organization (CMO) site located in Indiana.
• This role focuses heavily on CMO management, quality assurance activities, batch documentation review, and compliance oversight.
• You will partner closely with cross‑functional virtual teams including Quality, Operations, Technical, Engineering, GCMC, and Regulatory groups.

Key Responsibilities: 

• CMO Quality Oversight (Primary Focus – ~80%).
• Manage day‑to‑day quality oversight of the CMO manufacturing operations.
• Build and maintain a strong working relationship with the CMO’s quality and operations teams.
  Conduct oversight related to aseptic processes and ensure compliance with internal and external standards.
• Participate in virtual site operating team meetings and cross‑functional project discussions.

Quality Assurance Activities: 

• Review batch records, validation protocols, engineering run protocols, and other GMP documentation.
• Support investigations, deviation management, and root cause analyses.
• Prepare and manage change controls as needed.
• Ensure operations meet cGMP requirements and quality expectations.
• Regulatory Support (~20%) Collaborate with internal GCMC and Regulatory Affairs partners.
• Understand regulatory considerations impacting product manufacturing at the CMO.
• Ensure documentation and quality processes align with regulatory expectations.

Required Skills & Experience (Must‑Haves): 

• Quality Assurance / Quality Management experience (ideally 7+ years).
  Regulatory experience is sufficient to interface effectively with regulatory and GCMC teams.
  Aseptic manufacturing experience (highest priority due to product risk profile).

Preferred Skills: 

• Experience managing or overseeing CMO relationships.
• Strong understanding of aseptic operations in a GMP environment.
• Experience with aseptic medical device manufacturing is ideal.
• Ability to navigate complex cross‑functional environments and virtual team structures.

Work Environment & Team Structure: 

• Fully remote team based primarily in the U.S.
• Hiring manager and most team members operate on Eastern Time.
• Cross‑functional partners are geographically dispersed.
• Collaboration occurs primarily through virtual meetings, with in‑person interactions during CMO site visits.

Qualifications: 

• Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role.
• At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, and Documentum platforms.
• Command of English language required and multi-lingual is a benefit.
• Strong verbal and written communication including presentation skills.
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers.
• Demonstrated ability to manage multiple projects and priorities.
• Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader.
• Demonstrated excellent organization skills.
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
• Developing personal leadership to manage cross functional projects.
• Developing ability to resolve conflicts.
• Takes initiatives and is proactive, persistent.
• Has a broad GMP and technical know-how to handle emerging issues.
• Able to report remotely and deliver work independently.

Schedule: Must be able to align with an East Coast–based team