VP, Quality

Location Indiana
Job type: Permanent
Contact name: Cloe Broad

Contact email: cloe.broad@rbwconsulting.com
Contact phone: +16178024167
Job ref: CBINVP
Published: 3 months ago
Expiry date: 09 Nov 2024 23:59
Startdate: September 2024

VP Quality

CDMO - Aseptic Manufacturing

Global Oversight

Indiana

​RBW are partnered with an ambitious CDMO, focused on Sterile Manufacturing of Injectable, High Potency products. Recently seeing huge success in securing a $250m investment to expand existing sites! It's due to be a very busy, very exciting year for this CDMO as they are looking to build their teams across Quality, Operations, and Engineering. With over 60 years in the industry and backing from large global partners, this CDMO present a long-term, stable opportunity for your own development. They also champion giving back to their community by organising events such a community park clean-up days or building homes for those in need, they prioritise having a positive impact on the environment around them - showing they care about both people and the planet.

The VP, Quality will be responsible for operational oversight of facilities both in US and Europe, managing the Quality strategy and working closely with teams across the business to ensure GMP compliance. You will also be responsible for the implementation of policies, practices, procedures, standards, and systems.

Responsibilities

  • Maintaining the company aware of all global regulations that may impact the Global business operations

  • Establishing a surveillance process for all deficiencies & observational themes surging in the global regulatory environment.

  • Maintaining up to date all Drug Master Files of the company and collaborating with clients to keep their submissions up to date.

  • Establish & Manage all communications with regulatory agencies like FDA (ESG & CDER Direct), EMA, Japan, Korea, Australia and others.

  • Perform Quality & Compliance Internal corporate Audits.

  • Interact with the Product Development groups to manage and submit all regulatory filings for customer as well as internal needs.

  • Help redact and review responses to Regulatory bodies that had conducted audits at our sites.

Requirements

  • Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.

If you would like to discuss the details of this opportunity to find out if it could be a fit for you and your experience, please reach out to me directly by calling +1 617 802 4167 or emailing Cloe.Broad@rbwconsulting.com

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