Associate Director

Job Title: Associate Director, Quality Department: Quality Reporting To: Head of Quality, UK and Ireland Job Purpose Lead Quality activities to ensure Millicent operates in compliance with regulatory requirements and provide Quality support for the Larne site and Millicent commercial products. Key Duties and Responsibilities Management and Quality oversight of the product quality complaints system for Millicent products. Review and trend complaint data and present findings for Quality Management Review.

Provide Quality oversight of Third-Party Provider complaint intake centre. Develop and maintain the Millicent Quality Management System to ensure appropriate systems and procedures are in place for the management and control of regulated activities. Participate in the self-inspection programme and ensure systems and procedures used at Millicent comply with regulatory requirements.

Prepare for and follow up on external audits and regulatory inspections. Stay current with emerging regulatory guidance within the industry. Work collaboratively as an integral part of the Larne QA Team.

Ensure effective partnership with other areas of the company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance. Represent Quality in internal and external meetings and teleconferences in a positive, collaborative manner. Demonstrate high levels of leadership and people management skills.

Contribute to the review of company policies and procedures. Undertake any other duties assigned by Senior Management. Human Resource Management Adhere to the Company's policies and procedures.

Provide guidance and support to team members. This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual job holder works.

It is not intended to be rigid or inflexible and may alter as the company's strategic direction changes. Person Specification Essential Skills Education Science degree. Experience Minimum 5 years' experience working within the Quality department of a pharmaceutical company.

Experience at a managerial level. Specialist Knowledge Experience of product quality complaint investigation. Knowledge of FDA regulations.

Experience of Quality Management System maintenance. Knowledge of dosage forms and drug delivery. Special Skills and Dispositions Excellent interpersonal and leadership skills.

Ability to be flexible and adaptable to change. Proactive and self-motivated, with a high level of initiative and persistence. Demonstrable ability to set and meet targets.

Experience working within a multidisciplinary team. Demonstrable ability to communicate fluently in English, both orally and in writing. Location Available to attend the place of work in Larne, UK.

Amenable to work-related travel as required. Desirable Skills Science degree (preferably Pharmacy). Experience in small to medium-sized pharmaceutical companies.

Experience in the investigation and trending of product quality complaints. Experience of working in an FDA-regulated environment. WHJS1_NI