Senior Quality Manager

Colorcon is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture.

Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base.

We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals.

Platinum Rule: We treat others the way they want to be treated

Empowerment: We trust our colleagues with responsibility and decision-making

Keep Getting Better: We create an environment for constant improvement, to be the best we can

Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals

Customer Focus: We put our customers’ needs at the heart of everything we do

Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate

At Colorcon we value diversity. Typically, that means diversity in people. But here, we also appreciate and respect a diversity of possibilities around our professional roles, creative team-oriented solutions, projects and career paths.

Along with diversity, we believe in empowerment. We encourage our employees to approach challenges in imaginative and proactive ways. We welcome applications from candidates with disabilities and encourage you to let us know if you require any reasonable adjustments during the recruitment process.

The Senior Quality Assurance Manager is responsible for leading the Dartford Quality Assurance function and ensuring the continued effectiveness of the site Quality Management System. The role has overall responsibility for the quality assurance, raw materials, finished goods and QA auditing teams at Dartford.

The position serves as the primary quality authority for product disposition decisions and ensures that raw materials and finished goods are released in accordance with approved specifications, GMP principles, EXCiPACT, ISO 9001 and applicable corporate requirements.

Responsibilities, Duties & Requirements

Lead, maintain and continuously improve the Dartford Quality Management System.

Ensure compliance with ISO 9001, EXCiPACT, IPEC guidelines and applicable regulatory requirements.

Approve and maintain Quality Assurance procedures, policies, specifications and controlled documentation.

Chair Quality Management Review activities and monitor site quality performance metrics.

Lead, develop and manage the QA, Raw Materials, Finished Goods and QA Auditing Teams.

Establish departmental objectives and ensure alignment with site and corporate quality goals.

Provide coaching, mentoring and performance management for team members.

Ensure quality resources, succession plans and departmental structures support current and future business needs.

Support Customer Audits and Supplier Audits where necessary.

Promote and drive quality culture and continuous improvement initiatives across the Dartford site.

Provide quality leadership to support business growth, operational excellence and customer satisfaction.

Act as a key member of the operations leadership team, contributing to business planning, risk management and organisational decision-making.

Develop and implement quality strategies that improve compliance, efficiency, product quality and customer confidence in alignment with site, regional and global quality objectives in all areas of responsibility.

Analyse quality trends to identify risks, opportunities and resource requirements.

Collaborate with global quality, operations, supply chain, procurement and commercial teams to deliver strategic quality objectives across the organisation.

Approval of standard operating procedures, ensuring documentation is controlled, current and available as required.

Provide timely and appropriate responses to customer requests received via the Quality inbox.

Attend customer meetings where necessary.

Manage the change request system at a regional level ensuring timely completion of associated activities.

Minimum Qualifications

Able to act as the site quality authority and make timely, risk-based product disposition decisions.

Strong strategic thinking and business acumen, aligning quality objectives with site, regional and global priorities.

In-depth understanding of quality management systems, GMP principles, ISO 9001, EXCiPACT, IPEC guidelines and applicable regulatory requirements.

Able to analyse quality trends, identify emerging risks and opportunities, and determine resource requirements.

Able to communicate complex quality information clearly and influence stakeholders at all levels.

Capable of balancing compliance, customer expectations and business needs while maintaining accountability for outcomes

Extensive quality leadership experience within pharmaceutical, chemical, food, excipient or other regulated manufacturing environments.

Proven experience leading Quality Assurance and Quality Control functions, including raw material and finished goods testing and release.

Demonstrated experience maintaining and continually improving a site Quality Management System.

Experience chairing Quality Management Review and reporting quality performance metrics.

Experience leading customer and supplier audits and supporting external certification or regulatory audits.

Proven experience managing controlled documentation, specifications, procedures, change controls and electronic approval workflows.

Experience leading, coaching and developing multi-disciplinary quality teams, including succession and resource planning. Qualified lead auditor or equivalent audit training.

Responsibilities

Experience with regional change control or quality systems responsibilities.

Experience contributing to global quality strategy, forums or improvement programmes.

Formal training in root cause analysis, CAPA, risk management or continuous improvement.

Quality Management System leadership, governance and continual improvement.

Product disposition, raw material release, finished goods release and QA auditing oversight.

SOP, policy, specification and controlled-document approval and maintenance.

Quality risk management, trend analysis, performance metric development and management review.

Customer and supplier audit support, with clear and timely follow-up.

Change control leadership and timely completion of associated quality activities.

Strong leadership, coaching, mentoring, performance management and succession planning skills.

Excellent written, oral and presentation skills, including communication with customers and senior leaders.

Confident use of Microsoft Office and electronic document or approval systems, including DocuSign or equivalent.

Flagship House, Victory Way,

Crossways, Dartford, DA@ 6QD

United Kingdom

Annually - 0.00 - 0.00