Tower is a rapidly growing, innovative company specialising in temperature-controlled packaging solutions for the life sciences and pharmaceutical industries. This role ensures that the products and services provided to our clients are fit for purpose, consistent, and meet both external and internal standards. Working with both the Global Head of Operations and the CEO the role will be responsible for the delivery and sustainability of a quality culture across Tower.
The Quality Assurance and Compliance Manager (QACM) will be responsible for overseeing the daily Quality and Compliance requirements of the Tower Integrated Management (TIMS) and Quality Management System (Dot Compliance), ensuring the global delivery of our products and services. The QACM will coordinate and manage the quality and compliance across the entire customer process, monitor supplier performance, and engage with customers to address any concerns. Key responsibilities include conducting internal audits, managing the CAPA (Corrective and Preventive Action) system, and driving continuous improvement in Quality and Regulatory compliance.
Key Responsibilities:
* Provide leadership by ensuring team members have the necessary education, training, and experience to excel in their roles.
* Ensure adequate resources are available to execute QA processes, mitigate compliance risks, and maintain quality oversight of site operations.
* Work with internal teams and external clients to address quality issues, conduct investigations, and drive improvements in product, process, and business performance.
* Lead initiatives to enhance quality and drive continuous improvement.
* Support the creation of robust processes to ensure product, service delivery and customer satisfaction while optimising efficiency and cost-effectiveness.
* Prepare data for management and committee meetings and manage key quality and compliance metrics.
* Ensure that quality objectives meet the business goals.
* Promote a quality driven culture throughout the business.
People:
* Design, develop, and facilitate training programs to meet quality and regulatory requirements.
* Maintain a framework for delivering training on products and processes for both internal and external stakeholders.
* Deliver a training schedule to ensure product and process knowledge is maintained through refresher cadence, workshops, toolbox talks, CAPA's and change controls.
* Monitor training effectiveness and ensure competency levels are monitored, and incidents reported and managed through KPI's.
* Manage customer expectations and ensure quality standards are met by managing the quality team and collaborating with the Regional Operations Manager.
* Support Customer Interactions and provide support for customer inquiries, surveys, and requirements.
* Promote a culture of safety by ensuring adherence to health, safety, and environmental policies.
Products (Technology) and Services:
* Manage complaints and oversee the receipt, categorisation, and resolution through the Tower eQMS system, Dot Compliance.
* Manage the quality investigations and work with relevant stakeholders to correctly identify root cause trough 5 why analysis.
* Facilitate the CAPA Process by leading champions to ensure that Corrective Action and Preventive Action (CAPA) are delivered, and effectiveness checks ensure continued customer satisfaction.
* Conduct QMS CAPA meetings with relevant stakeholders to ensure effective quality management.
* Assist with new product launches from an operational quality perspective.
* Oversee quality inspections on products, services, and systems.
* Promote recommendations on how to improve the system technology supporting the quality functions and deliver a more holistic and effective approach to enhance usability, data driven decisions and reporting capabilities.
* Evaluate new processes and change controls to assess risks and maintain product and service quality.
Process:
* Manage quality policies, records, and external certifications.
* Stay Informed on Standards: Maintain knowledge of ISO 9001, ISO 45001, ISO 14001, UKAS 17025 requirements, and regulatory expectations.
* Oversee compliance with Health, Safety, and Environmental regulations in global Centres of Excellence.
* Lead customer, regulatory, and registrar audits, ensuring corrective actions meet expectations.
* Support managers in negotiating and implementing quality agreements.
* Interpret Regulatory Requirements: Provide guidance on quality and regulatory requirements to support business objectives.
* Ensure awareness of applicable regulatory and QMS requirements throughout the organization.
* Track and drive key quality metrics, including training, quality events, regulatory compliance, and lead relevant analytics and productivity initiatives.
Job Requirements
Education
* Quality Assurance related Degree or ISO9001 qualification are essential for the role
* Master's degree in life sciences or related field preferred
* Recognised Quality-related qualification e.g., Chartered Quality Institute (CQI) - desirable but not essential
Experience
* Strong knowledge of ISO regulations and guidelines required
* Experience with internal and external audits
* Minimum of seven years progressive experience in the regulatory compliance environment
* Must be able to interpret and apply GXP regulations and guidance's
Skills
* Familiar with Quality Management Systems
* Ability to build and maintain excellent working relationships internally and externally.
* Experience in leading, growing and mentoring high performance teams.
* Excellent interpersonal and communication skills.
* Ability to multi-tasks and adjust priorities, as necessary
* Exceptional attention to detail.
* Attitude of continuous improvement
Tower Cold Chain is committed to Equal Opportunities in employment and service delivery. The policies and practices of the Company aim to promote an environment that is free from all forms of unlawful and unfair discrimination and values the diversity of all people.
We offer £Competitive +Bonus and Benefits. #J-18808-Ljbffr