Quality Director - De Novo, have strong GCP? Manage all GxPs!

Reference: MG140820QD

Expiry Date: 13-12-2020

Categories Clinical Research, R & D

Salary: On Application

Job Type: Full Time

Location:
Cambridge
Cambridgeshire
United Kingdom

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Job Description

Quality Director - De Novo, have strong GCP? Manage all GxPs!

Note on Location

This role will be based from my client’s new offices in South Cambs / Herts borders, and is within easy commute of Essex, Suffolk, Norfolk on the one side, North London and Herts, as well as Beds, Northants and of course, Cambridgeshire.

Post-Covid, they will convene an office but this will not be every day!

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 speciality 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

It is likely you will have around 15 years’ experience in quality assurance, ideally for GCP although this could be from auditing, process improvement or quality assurance management roles, and ideally 5-8 years in a leadership role, with people management.

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.  Relocations will be considered!

The role comes with a competitive Director level salary (even to larger pharmaceutical companies), a decent performance bonus and a stock plan. The company are willing to buyout a certain amount of stock and bonus from you potentially leaving your current employer, for the right person.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Matt Greig on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities.

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