EMEA QSHE Lead

Description:

EMEA QSHE Lead - UK OR Europe, REMOTE - to £85k plus car allowance, bonus and benefits.
A superb opportunity to join one of the best Facility Management companies in Europe. This is a replacement role for someone who has been promoted internally. We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from home and will involve some travel. We require someone who has worked either for a Pharmaceutical company or a Facilities management company on site at a Pharma client. This role is focusing on the quality side of things and you will have a background in managing compliance, experience of QMS and be able to conduct investigations around CAPA.
Three direct reports
30% travel
Client is a large pharmaceutical/life science company.
Job purpose
Provide oversight and regional strategic leadership across quality, safety, health, environment, risk management and business continuity throughout the EMEA contract.
Work with other regional and global QSHE teams, subject matter experts and the wider account team to support and advise the operations teams in accordance with company, statutory and client procedures and objectives.
Be part of the central account leadership team and develop a QSHE strategy aligned with the account specific plan and objectives.
Operational responsibility in the EMEA account for leading the output from a team of QSHE people based in the region.
Key responsibilities and activities
• Successful client and regulatory audits of GxP activities across the EMEA sites.
• Timely reporting and investigation of quality and safety related incidents and audits.
• Added value to the business through implementing efficient, standardised systems and processes.
• Flexible to perform ad hoc assignments (special audit requests, serious quality investigations, due diligence etc.)
• Continuous development on technical, business skills and knowledge.
• Manage HSE policy and system framework for the client account in coordination with Group Health and Safety and client EHS representatives.
• Take EMEA responsibility for HSE procedure and systems for delivered services that meets Group Health and Safety policy and client EHS policy requirements where required.
• Take EMEA account responsibility for the client Quality Management System (QMS) where implemented in line with contract and scope of QMS
Job profile:
• This is an important role which has wide exposure to management providing a unique opportunity to learn the company’s varied and diverse activities and has great opportunities for future career progression.
• The role is also a senior member of the Pharma and Life sciences Quality & Compliance group, which provides support to the wider global pharmaceutical, Healthcare and Life sciences operational teams working on other Global Pharmaceutical accounts. The group is responsible for conduct of audits, training, and quality / safety investigations, all of which ensure GxP and SHE regulations are satisfied.
• This position is home based, however travel is expected within EMEA to visit the relevant client sites.
Essential
• Solid grounding and practical experience in working in the pharmaceutical or life sciences environment in a Quality of HSE function.
• In-depth knowledge of a regulated GxP environment and the standards which must be met to assure patient safety and product quality.
• An EU Quality or HSE qualification.
• Background in auditing with a supporting ISO Lead Auditor qualification.
• Reporting skills – ability to write persuasive and effective reports and communications, which clearly define findings and their causes and recommendations.
• Analytical skills – ability to systematically gather information from a variety of sources, analyse information, identify implications of data, draw appropriate conclusions, and generate processes to evaluate the consequences of choosing each alternative.
• Excellent communication, influencing and facilitation skills.
• Proven experience in working across international geographic boundaries.
• Self-motivated and able to work on own initiative within a team environment.
• Fluent English (and other relevant major language is an advantage.
Desirable:
• Commercial awareness and judgement with an understanding of wider implications of actions.
• Experience of having operated successfully within an outsourced B2B environme