Job Description

The role focuses on compliance, customers and continuous improvement activities to create a total quality culture and reduce costs in line with best practice procedures. This role requires delivering effective management system across the division that drives performance improvements in the areas of customer quality, productivity, and compliance against required standards. An individual in this role provides support and leadership to the site quality and manufacturing teams in identifying quality systems and regulatory compliance gaps, leading or facilitating activities to drive continuous improvement for customers and manufacturing teams, and helping to leverage best practices across the organization.

Hands on responsibility for the execution of an effective quality management system providing quality oversight and leadership to the quality team as well as providing quality support to the various production departments. Develop strong Customer relations through regular interaction with Customers, maintaining a high standard of outcome from Customer audits and by ensuring supply of the highest quality product. Drive improvement activities to support quality and financial performance, lead key improvement projects evolving through customer requirements, legislative changes and amendments of the relevant accredited standards to ensure compliance with standards and accreditation audits. Draft, review and implement changes to our quality system, standard operating procedures and policies to satisfy customer and third-party requirements.

Role Responsibilities

Provide authoritative guidance and advice on all aspects of quality to the management team; train and coach employees improving knowledge and skills in quality improvement compliance gaps. Provide strong stakeholder support, to facilitate fast implementation of key business improvements. Recruit, develop, motivate and manage a team that optimises quality operations and is flexible in the support it offers the business, meeting current and future needs Promote a total quality philosophy at all levels developing a culture of right first time and continuous improvement Oversee changes to the quality system, standard operating procedures and policies to satisfy customer and third-party requirements. Review the quality system as appropriate to ensure full compliance with customer and company best practice guidelines and maximize effectiveness of production contributing to consistent operational performance and standards whilst ensuring conformance standards. Oversee the customer complaint process; to ensure root cause is identified and robust CAPA are put in place to prevent recurrence Review amendments to standards and ensure compliance with accreditation bodies Support introduction of new equipment on site and validation processes to meet safety and customer expectations Produce data and present reports for site, customers and corporate as required. Work with production and support functions to maintain and improve our quality systems and adherence to operational best practice thus guaranteeing compliance to external and internal standards Develop strong Customer relations through regular interaction with Customers, maintaining a high standard of outcome from Customer audits and by ensuring supply of the highest quality product The facilitation of customer facing activities and communications including customer visits, responses and preparation of information whilst leading site audit activities (external body, internal and customer) Support senior leadership team in introducing systems and procedures to enhance operating effectiveness and efficiencies Drive improvement activities to support quality and financial performance, lead key improvement projects evolving through customer requirements, legislative changes and amendments to GMP best practice to ensure compliance with standards and accreditation audits. Lead improvements to enhance quality system and ensure optimum process in place to meet customer specifications whilst maximizing production Contribute ideas and participate in ongoing business improvement initiatives to reduce overall operating costs, improve margin and provide input into the strategy and operations of the site. Identify improvement projects and continuous improvement initiatives in line with site and corporate requirements to improve quality and safety and work with colleagues to implement these

Knowledge, Skills, Experience

University degree or equivalent by experience Internal/lead auditor qualification Demonstrable experience of leading change Approachable nature Organisation skills to be able to manage effectively remotely Be able to empower others Supervisory experience Working and audit knowledge of relevant accredited standards Experience in a manufacturing/production environment ideally with experience within a pharmaceutical environment and knowledge of Industry standards and guidelines Demonstrable experience of validating new equipment and processes Knowledge of Good Manufacturing Practices Root cause analysis and problem-solving techniques Skilled in information handling, analysis and presentation Customer relations skills Project management and problem-solving skills such as 6 Sigma, or other business improvement model

Behaviours

Inspiring and motivating others through clear vision and ability to convey strategies Coaching & Developing people - The ability to teach operational skills to others and mentor/coach accordingly Managing performance - Ability to monitor and evaluate performance and take appropriate action. Communication - Ability to convey ideas and decisions to internal and external customers Organisation - The ability to judge situations accurately and make sound operational decisions to deliver results on time Analytical thinking Tenacity Concern for standards and Results focused Determination - Ability to overcome obstacles Rational Persuasion Negotiation/consultation skills Commercial awareness Influence/Persuasiveness - Ability to influence and inspire others to act Efficiency Focused Continuous Improvement - The ability to continually monitor and review current working practices and make the best use of resources to improve organisational results

Other Requirements

Flexible and adaptable to change and prepared to take on additional responsibilities with other duties as required to meet business needs. Successfully adapts to changing demands and conditions. Be able to be self-motivated, standards driven, with a keen eye for detail whilst being team focused and harnessing collaboration and co-operation of others.