Global Quality and Compliance Director - UK REMOTE - to £100k plus package.
We are seeking an experienced Quality Assurance and Compliance Director who has experience working in the LifeSciences / Pharmaceutical sector who has a good grasp of GMP regulations. You will be managing a Large Pharmaceutical account globally. This role requires someone who exudes confidence and who is a real diplomat who is tactile but firm. We need someone who can get what they need to get from people but in a way that still makes them welcome. You will be developing solutions to comply with GMP and the role will involve travel and has superb career progression.
Job Purpose
The Global Quality Compliance Lead is part of the Pharma Quality & Compliance Group and has responsibility for oversight of Quality and Compliance globally across the CLIENT which covers both the Human Health and Animal Health divisions on the account. This is a high-profile role providing wide exposure to senior management, provides unique opportunity to learn the company’s varied and diverse activities and has great opportunities for future career progression.
The Pharma Quality & Compliance group provides support to the regional QC teams who are dedicated to specific contracts/clients. The group conducts audits, regulatory intelligence and manages the global Quality Management System for the Pharma business. The group is the authority for all Quality and Compliance strategy and operations globally, where services are delivered in the highly regulated areas of Pharmaceutical & Consumer Health.
Serving as part of the senior leadership team on the account, the role will support quality and compliance activities globally region for both human and animal health portfolios. Travel to sites and locations across the global account as required and needed.
Accountabilities – Client Focused
• Manage quality and compliance related activities and oversee GxP compliance aspects of operational activities carried out for the CLIENT globally
• Perform audits of all ’GxP’ services which we provide to the CLIENT as required.
• Work with CLIENT teams to investigate root-causes, analyze and implement corrective and preventative actions, particularly where GxP deficiencies are noted.
• Influence and coach senior management to ensure robust quality systems are in place and followed.
• Present quality related topics to senior account and CLIENT management teams through local, regional, and global governance meetings.
• Develop strong working relationships and maintain communication with key CLIENT personnel.
• Manage and provide oversight to the global Quality and Compliance staff on the account.
• Conduct site visits as required to implement quality systems and ensure regulatory/CLIENT expectations are being met.
• Advise CLIENT, of any changes in legislation which may impact the business.
• Conduct training in GxP and QMS topics, to the wider operations and management team.
• Support operational and performance management deliverables related to quality and GxP KPI targets on the account.
• Ensure quality and compliance oversight of vendor delivered GxP services on the account.
• Execute various processes (e.g., QMS / documentation control, change control, risk management, non- conformance and CAPA management, 3rd party management) in compliance to relevant standards.
• Actively work across the global portfolio as part of the CLIENT senior leadership team.
Accountabilities – Above Account Focused or “what you have to do”
• Actively serve, support, and participate as a Quality Assurance Leadership Team (QALT) member for the Global Quality & Compliance organization.
• Execute special audits as required by Group Chairman, Chief Operating Officers, or other senior executives, to investigate specific issues on behalf of the company.
• Assist with management, development, and continuous improvement of the Global Quality Management System for the pharma business.
• Perform investigations and special projects as required by the Global Quality & Compliance Executive.
• Assist the business development teams in bidding / securing new business.
Key Performance Indicators (KPIs) or “What it will look like when you are doing the job well”
• Successful CLIENT and regulatory audits of our GxP activities across CLIENT sites globally.
• Timely reporting and investigation of GxP quality related incidents and audit findings.
• Added value to the business through implementing efficient, standardized systems and processes.
• Good team player in an international environment, with an ability to be self-managed.
• Flexible to perform ad hoc assignments (special audit requests, serious quality investigations, due diligence etc.)
• Continuous development on technical and business skills and knowledge
Skills, Knowledge, and Experience
Essential
• Candidates should have a solid grounding and practical experience in working in the pharmaceutical environment, particularly in a Quality function, laboratories, and facilities management areas.
• The candidate should have an in-depth knowledge of working in a Pharmaceutical regulated (GxP) environment, and the standards which must be met to assure patient safety and product quality.
• The candidate should possess a substantial auditing background.
• Ability to write persuasive and effective reports and communications, which clearly define findings and their causes, and recommendations made.
• Must possess strong analytical skills. The ability to systematically gather information from a variety of sources, analyses information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem.
• Ability to apply Quality Risk Management principles.
• As this role interacts with senior CLIENT representatives, and senior staff, excellent communications skills (verbal and written) are required, with an ability to recognize the values within different cultures and acknowledge different ways of working.
• Fluent English + other relevant major languages is an advantage
• GxP Quality professional, ideally within pharma or facilities management
• Minimum 5 years' GXP Pharmaceutical Quality experience with significant recent experience in senior positions.
• Extensive knowledge of current market conditions.
Desirable - profile of the candidate we are looking for:
▪ Clear thinker with determination and energy, good planning abilities, well-organized and seeking perfection.
▪ Assertive but personable.
▪ Excellent communication and interpersonal skills with a wide spectrum of personalities.
▪ An influencer - willing to lead by example and work on own initiative.
▪ Strong attention to detail and accuracy.
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▪ Good numeracy and oral and written communication skills.
▪ Able to work under pressure, whilst ensuring deadlines are met.
▪ Able to manage, and respond positively to, change.
▪ Keen to achieve self-development.
▪ Challenge the status quo to achieve a culture dedicated to continuous improvement and best practice.
▪ Focus and push both self and others to achieve targets and results.
▪ Seek ways of perfecting things, raising standards, reducing errors, and overcoming omissions.
▪ Smooth relationships when difficult circumstances prevail and develop a culture of trust both within and outside the team.
▪ Be alert to changing situations, show flexibility in approach, adaptability in difficult circumstances, and continuously strive to achieve a result.
▪ Commercial judgemental and understanding of wider implications of their actions
▪ Project management experience
Competencies (Operational & Core)
• Growth, Client and Customer Satisfaction/Quality of Services Provided
• Rigorous management of results
• Brand notoriety
• Analysis & decision making
• Leadership & people management
• Innovation & Change
• Industry acumen
• Planning & organization