Job description:

Summary of Job Purpose and Person Specification

The post holder shall be responsible for managing day-to-day Quality activities for the US and/or UK facility. The post holder shall be responsible for ensuring solutions are ethical, regulatory compliant, and responsive to client needs.

Organisational Position

The post holder reports to the Director of Global Quality, Head of Global Operations, or appropriate designee.

Responsibilities

o Managing the Quality Assurance functions in the US and/or UK ensuring the delivery of a nimble, efficient, and compliant quality management system.

o Ensure that the structure and organization of the quality teams deliver the highest standard of Quality Assurance paying regard to the US and European regulatory requirements.

o Establish firm and effective means of communication and working between teams.

o Maintain professional and productive relationships with customers.

o Interact with customers and regulators, when required, during audits, inspections etc., serving as an ambassador for quality.

o Ensure that quality assurance and compliance is understood at the US and/or UK facility and by all applicable employees.

o Promote continuous improvement and champion change.

o Encourage the use of quality measurements and lead and host regular Quality Management Review (QMR) meetings.

o Support and participate in Quality Control activities.

o Host all regulatory and client audits.

o Work with department leaders to address and respond to any audit findings.

o Ensure appropriate processes and procedures are in place, keeping compliance at its highest level.

o Take the lead in ensuring that suppliers and customers are supportive of quality aims.

o Champion training and continuous professional development for all staff.

o Audit suppliers.

o Ensure that all contracts, technical agreements, and equivalent documents are appropriate and properly signed off.

o Support the safeguarding of data and confidential information.

o Support the health and safety requirements.

Competencies and Skills:

· Strong organisational skills with multitasking capabilities.

· Ability to interpret and apply cGMP and company SOP knowledge.

· Strong interpersonal skills and the ability to manage, motivate, and influence quality work behaviours in self and others.

· Flexible, enthusiastic, and highly motivated to work in a challenging environment.

· Proficient knowledge of various computer applications to include Microsoft Office applications.

· Position entails a high level of independence, initiative and requires an aptitude for attention to details, investigation, analysis and problem solving. Works mostly within set guidelines to achieve project goals. It is necessary to use specific and established procedures and creative initiative to accomplish tasks.

· Requires the ability to apply professional level knowledge and skills with applicable government regulations and company SOPs to ensure proper control of labels, labelling materials, packaging materials and randomization or treatment group assignments. Works with client Quality Assurance representatives to plan and execute facility visits or facility audits. Must be able to organize and plan workload to support all projects concurrently to meet deadlines. .

· Must have excellent verbal skills to effectively communicate to client and project team members. Able to initiate discussions with client Quality Assurance representatives or project team to anticipate special Quality Assurance requirements.

Qualifications / Experience

· Bachelor’s Degree in Business Management, Science, or Engineering or 5+ years relevant industry experience

· 5+ years experience working within a regulated industry in a Quality role or 7+ years experience working in a regulated industry wherein 2+ years was working in a Quality role

· 2+ years experience managing people/teams

· Knowledge of the supply of unlicensed medicines (preferred)

· Knowledge of regulatory requirements in US and Europe

· Excellent communication skills

· Able to motivate self and team

Monday to Friday (Full Time)