Quality Manager (System & Compliance)
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Quality Manager (System & Compliance)Apply Now
This is a management position in an ethical Solid Oral Dosage Pharmaceutical Formulation and Finished Product plant. This brief has responsibility for all of the Quality Systems and Quality Compliance functions at the Takeda Ireland Ltd Bray site, specifically covering the following areas:
- Quality support for Regulatory Affairs especially with regard to the Registration of new products (NDAs, SNDAs), supply of Clinical trials, Product Stability Programmes and the Launch of New Products to new or existing markets.
- Regulatory compliance function
- Quality Compliance and Quality Systems as per Standard Site Quality Structure.
- Prepare and present the Company for both immediate and routine Regulatory Inspections - primarily by the U.S. FDA. and the HPRA. In addition you may be involved in attending at or conducting overseas facility inspections.
- Responsible for the management of all Quality Systems and Quality Compliance, through management of the Quality Executives, and their associated teams.
- Develop the existing Quality Department and personnel so that a high quality of service in the fields of Quality Compliance, Quality Systems and Regulatory Compliance can be delivered to Takeda Ireland and to the GMS/GQ Group.
- Represent Quality Dept. on cross functional teams.
- Manage GMP related training.
- Formulate and implement training programmes for Quality personnel.
- Support the Operations of Takeda Ireland such that pharmaceutical products of the correct dose, strength, purity, efficacy and quality standard are delivered to our customers according to schedule and within budget.
- Take an active role in the recruitment programme and training process for Quality Department personnel.
- Act as the formal contact point with the HPRA, the FDA and other Pharmaceutical Authorities.
- Manage, direct, mentor and motivate subordinate staff.
- Act as a Lead auditor for external supplier audits. Assist in mentoring of new auditors
- Communication and liaison with production/scheduling departments.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Director other Officer appointed by the Board of Directors.
- Degree in science discipline is essential
- To have completed or be in a training program to obtain suitable educational background that meets the requirements of Article 49 of Directive2001/83/EC (desirable requirement).
- Minimum 5 years experience in a Pharmaceutical Industry
- Minimum 3 years Quality Assurance related experience.
- Minimum 2 years experience in a supervisory role.
- Excellent verbal and written communication skills
- Be a self-starter who is motivated and innovative
- Strong interpersonal and Communication skills
- Good organizational skills.
Job ID R0012353