Expiry Date: 21-12-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Quality Director – are you a GCP expert who wants a Head of QA (all GxPs) – M25/M1/M11 North
This role can be based 2-3 days a week from home and in my client’s new offices on the South Cambs / Herts borders, within easy commute of Essex and East Anglia, as well as northern Home counties and North London.
About this fairly unique Quality Leadership opportunity!
I am seeking that certain special kind of Quality leader, one who thrives on bringing structure and organizational processes and thinking to new and growing smaller innovator organizations. What you will inherit will require shaping and redevelopment, where you will provide Quality counsel for GCP and Research QA, you will also manage all the GxPs (incl. PhV, GcLP, GCP, IMP, GMP), including redevelopment of the quality management system, top level policies and SOPs.
This smaller organization has a vision for their specialty medicinal area (all their NMEs are novel), and this role reports to a VP of Regulatory who will support you build your own vision and the overall quality philosophy in the organization. This VP has their own regulatory objectives to deliver on, so we really are looking for a stand-up professional, who can take the mantle and run with it.
This role is a position which will in time have a full-time team reporting into it, at first it will be semi-virtual, using a mix of contractors and freelancers but as the company grows from their mid / late phase pipeline, this role will also grow into a full QA departmental head leadership role, with eventually full-time Quality / QA Managers / Sr Specialists supporting you!
The company is using a fair number of Contract Labs and Manufacturers, as well as CROs, which will also fall under your remit of course, for Quality Oversight, so working with vendors, on technical agreements, compliance, and OOS/Investigations, or Audit findings, will also be part of this role. Additionally, you will be responsible for the European region, for any inspections preparation and hosting, regardless of which GxP it is.
I cannot think too much of what this role does not include in terms of quality assurance and quality management, so you will have to work with the leadership team to educate, escalate, and prioritize, based on your compliance expertise, and risk-based assessment, to decide where your short-term and long-term efforts will be needed.
Experience & Background
This role is applicable to Director or Associate Director levels ready to take the next step, ideally you will have good GCP and/or exp from auditing, process improvement or quality assurance management roles. Good leadership and people management skills are required.
Equally, we welcome applications from individuals who have led a quality career with a larger pharmaceutical company, and now would like something smaller, where you can have fuller oversight and ownership of all the GxPs and quality / research quality processes.
Package, Benefits & COVID
We have a digital hiring policy in place and you can be both hired and on-boarded remotely, pending the office reconvening. There is a certain amount of flexibility after Covid, in terms of working from home.
The role comes with a competitive salary (even to larger pharmaceutical companies), a decent performance bonus and a stock plan.
To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to firstname.lastname@example.org. Alternatively, please press the red “Apply for position” button and follow the registration process.
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