Lead Candidate has the privilege of partnering with organisations who are growing something special, making a difference to society through improved patient therapies and care. One such partner, headquartered in the US, are now looking to appoint a QC Director to lead their GMP QC laboratories (including stability programs) with high customer service, on-time delivery, and exceptional compliance.
Their culture and priorities are different by design: focused on building long-term value for customers, committed to a service-culture mindset, technical excellence, and a collaborative and team-centred approach to doing business.
As they build a world-class CDMO for parenteral injectable drugs, they have recently completed construction of their GMP facility, but the journey has only just begun, which provides the opportunity to leverage knowledge gained over multiple careers to "do it right" in all respects.
This is where you come in - If you are an experienced, agile, and collaborative leader who possesses maturity, confidence, strategic thinking, and sound judgement, who naturally creates new ways to deliver exceptional results, we want to hear from you!
The QC Director reports directly to the VP of Quality and is a member of the company s Quality Leadership Team. You will work closely with the VP, Quality and the Operations department to define and implement the overall Quality Control program for performing chemical and microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). You will be influential in championing and developing the Quality Mindset through Engrained Quality and Quality Metrics into the Quality Control organization you will lead.
The QC Director will be responsible for leading a newly-formed team to implement the new GMP QC laboratories. They not only operate in accordance with all GMP compliance requirements, but also with a focus on delivering exceptional customer service. Leading this team will require both strategic management as well as a willingness to be hands-on in the laboratory on a daily basis.
Main aspects of the role include:
Practical implementation of FDA, EMA and other regulatory authority expectations for Quality Control, including at least three (3) years of first-hand experience participating and/or hosting audits and/or inspections related to Quality Control
Exceptional leadership skills and at least five (5) years experience leading teams to live a culture of delivery and compliance within a Quality Control environment
Leadership, communication, project management, and budget management, while maintaining extremely high quality, compliance, and efficiency standards
A competent and credible quality leader, you will lead with empathy and play the role of coach and mentor. A Bachelor s Degree in Science (Chemistry, Biology, Biochemistry) combined with a minimum of 10 years of biopharma industry experience with increasing responsibilities in Quality Control, of which at least five years has been in a role tied to QC testing for injectable drug products, is expected for a candidate to be successful in this role. Additionally you will have:
Advanced degree in Science (Chemistry, Biology, Biochemistry) preferred
Previous experience leading other leaders (e.g. experience leading managers/supervisors)
This is a genuinely rare opportunity to be involved in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, clients, and patients. They strive to be different, putting the team at the forefront of everything they do and every decision they make.
Based on-site in Fishers, Indiana, this role can t be offered fully remote but is flexible with a hybrid on site/home based split.
If you want to be part of something special from an early stage, please contact one of our Talent Champions today!