Global Quality Director
Global Quality Director – US based, remote with international travel
Our customer is led by a talented group of people, with an established customer portfolio and aspirations to grow. They have a globally recognised, multibillion $ parent, with over 20k employees.
As a CDMO our customer has a remarkable combination of technical capabilities and innovative applications, serving customers across biotech and pharmaceutical markets.
Reporting to the EVP, the Global Quality Director will lead the businesses total quality strategy across Active Pharmaceutical Ingredient, Excipient and Biopharma Raw Materials. The role also leads the regulatory requirements including but not limited to FDA, EMA & ICH.
The successful candidate will drive a culture of continuous improvement in support of commercial goals and quality as a competitive advantage.
As a technical authority, the Quality Director will advise the quality and regulatory affairs strategy across multiple manufacturing facilities, globally, ensuring the continuous improvement culture and local initiatives are embedded to enhance product quality and regulatory performance.
This role serves as the primary contact for customer facing communications for regulatory, quality, and commercial, whilst leading the pharma programme globally.
The Quality Director will ensure the businesses Quality Management Systems (QMS) are relevant for the businesses strategic and operational priorities; while overseeing quality assurance processes are in place and robust in support of quality, yield and efficiency goals.
An outstanding collaborator, the successful candidate will act as subject matter expert in support of central Supply Quality standards. As well as well working closely with colleagues across R&D, Operations and Supply Chain to harness the collective strength of the business to place quality at the heart of its strategic priorities.
We would love to hear from Quality and Regulatory Affairs leaders with a proven track record of success leading change and driving excellence in a global context.
As technical leaders, we would expect impressive academic pedigree in Pharmacy, Chemistry, Chemical Engineering, or related scientific field; with evidence of continued professional development. Qualification in quality management methods is preferred.
An In-depth knowledge of cGMP, ICH guidelines, and other pertinent global regulatory frameworks, as well as a background in API, excipient, and Biopharma manufacturing.
To execute a significant change program, applicants will be able to demonstrate strong leadership skills, with the ability to motivate and inspire matrix organisations behind a collective mission.
The need for excellent communication and interpersonal skills goes without saying, as this role will require the need to influence at all levels internally and externally alike.
Outstanding problem-solving and decision-making abilities, with a focus on driving results and continuous improvement. Candidates will be adept strategic thinkers, with strong business acumen who can operate within ambiguity and cut through the grey to reach well thought out decisions.
In return, candidates can expect an excellent compensation structure and benefits package. As well as the chance to work for a growing CDMO with a network of global resources and experience behind it.
If this summary has piqued an interest, then please contact andrew@leadcandidate.com for an exploratory discussion and learn more about this opportunity.