Head of QP

Impel has been retained to manage an exciting search for a Director to Senior Director level Qualified Person for one of our clients, a prominent Biologics company with a global footprint.
The Head of QP will be a key position within the Quality and Manufacturing organisation, acting as a subject matter expert for GMP and managing a team of QP professionals to prioritise varied complex projects. This position will be reporting to the VP of Quality and is seen as one of the most important functions in the 300+ fte Quality organisation at this 1000+ fte site.
A broad understanding of Quality (QA/QC/QMS) and Manufacturing would add value to how you manage the strategic and operational goals and clearly communicate your decisions to internal and external stakeholders. This is a role where being present and agile is extremely important.
Our client will also be launching a new site to expand their capabilities which adds another level of complexity to the growth goals of the organisation and the exciting challenges the QP department will be facing.
Responsibilities:
Provide key insight and help define short- and long-term operational and strategic objectives for the Quality, Manufacturing and QP operations
Managing 6 QP Delegates with the core function of batch disposition to guarantee the quality and safety of the products
You will be the key subject matter expert for GMP, providing guidance and expertise to support the manufacturing operations
Assisting in regulatory and compliance activities, ensuring adherence to industry regulations and standards whilst being able to think “outside of the box”
Providing support during regulatory inspections and contributing to the preparation for these business critical events
As part of the senior leadership team of the Quality organisation, you will have to make informed QP decisions that drive continuous improvement and align with the concept of 'fit for purpose' that will impact processes and analytical methods on a local and potentially global scale
Maintaining a strong presence on the shop floor whilst actively engaging with operational teams to enforce a culture of Quality and GMP excellence.
You will develop, mentor and train across the Quality and Manufacturing operations whilst leading by example to foster a GMP and Personal Development culture that impacts quality and compliance
Manage and assist with internal and external audits, including cause investigations and cGMP audits
Technical Profile:
10+ years’ experience as a QP (Qualified Person) with a minimum of an MSc in Industrial Pharmaceutical Science or a related degree that is recognised by Regulatory Authorities to permit QP status as per Article 49 of Directive 2001/83/EC
Experience with Biologics gained in an EMA/FDA regulated environment, is required
CDMO exposure a big plus
Exceptional working knowledge of GMP principles and guidelines
Proficient in one or more Technical Operational area, such as QA, QC or Manufacturing
Knowledge of scientific principles for the manufacture of biological molecules
In depth understanding of analytical techniques used for the analysis of manufactured biological products.
Personal Profile:
You will be someone that is known for a high-level attention to detail, critical thinking, analytical mind with strong problem-solving skills
Strong decision-making skills and a 'can do' attitude with the ability to work in a fast-paced, agile and matrix environment
You are someone who can prioritise multiple tasks, projects and work to stringent deadlines whilst being flexible to meet changing business needs
Communication is an extremely important part of this position, having an open and approachable personality and being able to share insights into “Why” you are making certain decisions will set you up for success
An opportunity like this comes around maybe a couple of times a year, so if this sounds like the next step challenge that will elevate your career - lets discuss.