This Pharmaceutical organisation is a global leader in healthcare advisory, communications, commercial, clinical and packaging services. Operating across two divisions encompassing north of 30 P&L's, this organisation employs 9,000 people globally with operations in 29 countries. This organisation has under went significant growth in recent years both nationally and internationally, tying in with the organisational strategic focus to transition from demand fulfilment to demand creation whilst expanding the organisation's geographical footprint. At the core of this organisation's values are Quality, Partnership, Ingenuity, Expertise and Energy. The Group Quality & EHS Leader will champion Quality but also embody the other core values at the organisations centre.
- Act as the key point of contact for internal and external stakeholders in relation to the organisation's Group's Quality and EHS risks. Stakeholders include employees, sites, businesses and divisions; clients; regulatory authorities, and third parties.
- Monitor changes to relevant, multi-jurisdictional legislation, regulations and best practice that could affect the inherent Quality and EHS risk to the organisation, its divisions and businesses, or the sufficiency of related controls. Disseminate relevant changes well-enough in advance to operationalize compliance.
- Communicate clearly and concisely with the Group's senior management in relation to Quality and EHS obligations and controls. Participate, as required, in Group and divisional Quality & Compliance committees.
- Provide ad hoc expertise and support to sites and businesses subject to client and regulatory Quality and EHS audits, but lack local expertise to meet the demands of such reviews.
- Mentor new hires commencing Quality and EHS roles.
- Act as the EHS Officer for the Group's head office in Dublin, Ireland.
- Develop a full understanding of how we currently deliver our core risk and compliance processes at the Group, divisional and business levels. Fully align Quality and EHS within these processes.
- Gap assess the organisation's Group's current controls with GxP and jurisdictional requirements. Validate findings with counsel (if necessary), and project manage remedial actions with the site, business and functional stakeholders.
- Refresh Group policies and procedures governing Quality and EHS.
- Develop, and in conjunction with the Group Risk & Compliance Team, periodically collect KRIs and KPIs pertaining to the businesses' levels of inherent Quality and EHS risks, and controls sufficiency. Scrutinise and report relevant facts and conclusions, including within the organisation's periodic Board reports.
- Fully align the Group's Quality and EHS auditing activities with the current systems and processes of the Group Internal Audit function.
- A strong background in Quality in the healthcare, pharma and/or CDMO industries with some EHS experience
- Minimum 5 years' experience in a Quality, compliance or audit role within a matrixed, multi-national organization with responsibilities that include managing external audits and conducting internal audits
- Excellent collaboration and communication skills: including verbally and in writing to clearly express logically-reasoned ideas in a simple, discernible fashion
- Proven ability to interpret and understand all relevant requirements and the applicability of such to the organisation businesses, and to assess the impacts of noncompliance
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.