Commissioning Lead

Responsibilities

• Delivers delegated elements of an annual business plan to time and budget.
• Manages and facilitates external certification audits.
• Serves as the single point of accountability for the entire Owner’s Representative engagement for a global pharmaceutical client.
• Governs scope and schedule, manages the client relationship, and owns overall delivery outcome.
• Provides expertise and guidance in supporting achievement of new certifications where appropriate.
• Organises and facilitates internal audits in the audit programme.
• Leads audits and produces audit reports.
• Utilises comprehensive expertise and investigates and interprets root cause analysis of instances of non-conformance, including recommending corrective measures and long-term preventative measures.
• Captures and coordinates reviewing of management system content for appropriateness, improvement, and implementation.
• Contributes to the identification of new systems and processes to drive efficiency, recommending improvements and innovations.
• Ensures information for quality reports is available, accurate, and delivered within agreed timescales.
• Produces communication articles, plans, and communication collateral.
• Coordinates activities reported in management reviews, collating, analysing, and presenting data and key metrics, analyses trends and provides recommendations and guidance.
• Provides recommendations for action to mitigate risk and improve management system effectiveness.
• Supports business development activities by providing specialised expertise and knowledge.
• Develops and delivers training.
• Manages and monitors performance of a supply chain, including support to suppliers as appropriate through training, guidance, and audits of their QMS capabilities.
• Works collaboratively towards the common goal of net zero carbon transition, and shares responsibility for the proactive identification and management of the associated carbon emissions and reductions during the delivery of work.

Requirements

• Strong knowledge and application of Quality Management Systems (QMS) and ISO 9001 standards.
• Experience managing external certification audits and supporting new certifications.
• Proven ability to lead internal audits and deliver clear audit reports.
• Strong analytical skills, including root cause analysis and implementation of corrective actions.
• Experience reviewing and improving management systems, processes, and controls.
• Experience developing and delivering quality reports, ensuring accuracy and timely submission.
• Strong data analysis skills; able to track trends and provide actionable recommendations.
• Experience supporting business improvement initiatives and driving process efficiency.
• Experience developing and delivering training on quality and management systems.
• Experience managing supply chain performance, including audits and supplier support.
• Line management experience with team leadership capability.

Qualifications

• Degree in Quality Management, Engineering, Business, or a related discipline (or equivalent experience).