Associate Director PVQA

(12 Months FTC)

Norgine

Harefield, United Kingdom

We have an exciting opportunity for an Associate Director to join Norgine in the PVQA role.

The person holding this position will report to Vice President of Corporate Quality.

The core responsibility of the role is to provide Global Quality Assurance leadership and oversight of global pharmacovigilance systems. Globally responsible for establishing a risk-based quality assurance process across the Norgine pharmacovigilance universe.

This will be a 12-month fixed-term contract role.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Develop, manage and oversee a global risk based audit program across the PV universe to ensure effective QA oversight of Norgine PV activities;
Manage and conduct PV audits of processes, affiliates and third parties and where required may include device vigilance within scope;
Partner with business areas through provision of consultancy regarding PV compliance issues;
Plan, conduct and close out or oversee PV audits as required;
Ensure continual compliance with policies, procedures and PV regulations through continual evaluation of PV processes;
Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements;
Host and/or coordinate PV inspections and responses to risk-based questionnaires. Supporting GxP inspections as required;
QA interface for partner audits, responsible to lead preparation for and hosting of partner audits of Norgine PV processes and responding to risk based questionnaires.

The job holder is accountable for:

Ensuring that a global risk based audit program is established that provides a measure of Norgine compliance with PV regulatory expectations and any gaps are identified and reported to responsible management;
Highlighting and escalating areas of concern and non-compliance with PV and proposing remediation to senior management;
Supporting GPV and country personnel responsible for GVP compliance in implementation of appropriate systems and compliance metrics;
Conducting audits in line with PV requirements;
Act as a Norgine PV QA ambassador in interactions with partners, regulatory agencies and industry bodies.

KEY COMMITTEE MEMBERSHIPS:

Development Quality Council (Chair and secretary);
Member of the Global Quality Leadership Team;
Member of the QPPV Office.

MAIN TASKS:

Act as functional lead for Global PV in line with global Quality objectives;
Responsible for establishment and oversight of appropriate risk based PV audit programs;
Act as expert consultant to the business for compliance related issues including interpretation of global regulations and requirements to lead implementation of the Norgine Global Quality strategy for PV QA;
Lead competent authority statutory inspections of PV, including preparation, facilitation and response support;
Support Global Quality where appropriate through performance of GxP audits;
Lead specific global Quality based projects when required;
Contribute to the Global Quality strategy as a member of the Quality leadership team.

RELATIONSHIPS:

The individual is expected to act within their area of responsibility with limited reference to manager;
The role is expected to be highly proactive in interactions across all Norgine functions that impact PVQA;
The job requires an ability to deal with a high level of technical complexity, excellent problem solving skills and a tolerance for ambiguity;
The role spans all of the global Norgine operations that are subject to PV controls and thus interfaces with many discreet departments;
The individual will have the emotional intelligence and diplomacy to operate effectively at Chief, VP and Director levels senior levels across Norgine and have excellent networking skills to interact across all Norgine functions and business units impacted;
The job requires excellent understanding of PV requirements that are outside of Norgine direct control and the ability to apply these within the Norgine business and ensure clear measure of levels of compliance are reported to Senior Management;
The position will interact with and make reports to VP and Director level across the organisation;
The individual will need to influence GVP, medical, therapy area and commercial personnel in a constructive way to support the Quality strategy;
The ability to influence and challenge others in a constructive way so as to deliver improvements will be key.

Requirements:

A scientific degree is essential with a solid relevant experience in Pharmacovigilance, of which a bigger part should be in PV QA;
Extensive specialist knowledge of pharmacovigilance and PV QA within the pharmaceutical industry;
Proven experience in establishment and oversight of Pharmacovigilance QA activities for both clinical trial/development studies and commercial marketed product;
Record of successful preparation and hosting of partner audits and competent authority PV inspections;
Strong analytical skills with highly developed quality system knowledge;
Excellent influencing skills and ability to establish effective working relationships with personnel at all levels within Norgine and suppliers;
Proven experience in auditing a wide range of GVP processes and suppliers;
Medical Device Vigilance experience is desirable;
Excellent verbal and written communication skills and ability to present effectively to groups;
Able to make data-driven recommendations/decisions and take appropriate action;
Ability to present effectively to groups.