HEAD OF QUALITY ASSURANCE
Major Pharmaceutical Company
Reference QA-68665
Our client is a world leader in the research and development of products to protect and improve health and well-being. Its core businesses are in pharmaceuticals and consumer health and the company is tremendously committed to research and development and to bringing innovative products to the market. Over the last 10 years, the company has developed a number of pharmaceutical bestsellers and has an extremely exciting new product pipeline. The company currently employs more than 500 people in Ireland.
THE ROLE:
The current Head of Quality Assurance is being promoted and will take on an international role. As a result the company is seeking to identify a successor. The key challenges of the role are to ensure that the continuing record of high quality standards and highest levels of compliance are consistently achieved and to drive change management initiatives in the Quality function in line with an on-going programme of change at the Irish site.
With one of the strongest pipelines of new products in the industry and the Irish site designated a new products launch site, the role of Head of Quality Assurance offers a number of business challenges which requires new thinking and the development of a partnership / one team approach with manufacturing to deal more effectively with a challenging high-volume environment, new product launches, highly complex interaction with the lab group and high capacity utilisation.
KEY RESPONSIBILITIES:
The appointee will:
- Provide leadership and strategic direction to the Quality Function, by setting goals and objectives and developing an empowered team.
- Manage the Quality Assurance Department to ensure compliance with all relevant local and international regulatory standards including cGMP practices and regulations, safety, environmental, hygiene.
- Manage resourcing, budgeting, performance standards and training for the department.
- Direct the planning and implementation of the Quality Systems, and take ownership of local Quality System in line with Global Quality System.
- Review and approve SOPs relating to IPC, QA, Validation, Production and Materials Handling and ensure IPC and QA SOPs are implemented.
- Develop a partnership approach with the business through working closely with Production, Materials, Supply Chain and all key internal and external stakeholders.
- Proactively seek and implement means of exceeding the company’s legislated environmental standards and contribute actively to meeting the requirements of sustainable development.
- Play a key role as a member of the Leadership Team in tackling business
PERSON PROFILE:
QUALIFICATIONS:
- Third level degree in Applied Chemistry, or an equivalent technical discipline. Postgraduate qualification is desirable.
EXPERIENCE:
- At least 10 years’ experience in a progressive pharmaceutical manufacturing environment, the last five at senior management level in the quality function. Experience in the API pharmaceutical sector preferred.
- Background in multinational bulk manufacturing sector preferably.
- Successful change management implementation and successful track record of project management skills.
KNOWLEDGE / SKILLS:
- Knowledge of cGMP practices and regulations, HACCP ISO and Scientific Regulatory Affairs.
- Developing and implementing quality improvement programmes.
- Compliance and system auditing in an FDA / IMB environment.
- Strong people management skills with the ability to motivate, develop and empower teams.
Candidates should contact John Glenny at MERC Partners on +353 (0)1 206-6700 for a confidential discussion or via email by clicking on the link below.
Click here to email John Glenny
Consultants inLeadership and Talent