Quality Systems Executive ( FTC 11 Months)

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Job Description
Quality Systems Executive
This is a fixed-term position for 11 months to provide maternity cover.
How you will contribute:

• Maintain and manage GMP documentation within the facility, including preparation, review, and control of Standard Operating Procedures (SOPs), Specifications, Guidelines, and Protocols.
• Oversee and ensure regulatory compliance with EU GMPs, FDA requirements, and ICH guidelines, including coordination and submission of documentation to support Regulatory Affairs.
• Manage key GMP Quality Systems such as Change Control, Training, and Documentation (Vendor Management), and support implementation of global Quality initiatives, including SOP harmonization.
• Provide Quality support to other TIL departments and contribute to continuous improvement and GMP-related projects across the site.
• Support and participate in audit preparation for regulatory and customer audits; act as a member of the audit and self-inspection teams as required.
• Lead, motivate, train, appraise, and discipline QA staff as appropriate; ensure timely completion of SOP reading, training, and assessments.
• Foster effective communication and collaboration across departments to uphold quality and compliance standards.
• Actively promote Takeda-ism values and a culture of safety, ensuring timely reporting of incidents and near misses.
• Carry out additional duties as directed by the relevant Manager or Site Quality Head.

Skills and qualifications:

• Primary degree in scientific discipline.
• Minimum of 5 years' experience in the pharmaceutical industry, preferably in a Quality Assurance (QA) role.
• Experience in regulatory compliance and use of electronic Quality Management Systems (eQMS) is desirable.

• Proven experience in leading, motivating, and managing teams effectively.
• Strong interpersonal skills with the ability to provide constructive feedback, coaching, and performance management.
• Demonstrated ability to foster a collaborative and inclusive team environment focused on priorities and results.
• Excellent organizational, investigative, and technical writing skills.
• High level of accuracy with strong attention to detail and a "right first time" mindset.
• Self-motivated, innovative, and able to adapt to changing priorities.

What you can look forward to with us:

• Competitive Salary: Including performance-based bonuses.
• Retirement Plan: Employer contributions to your retirement plan.
• Comprehensive Insurance: Employer-funded private medical insurance with dependants' cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.
• Electric Charging Points: Available at parking locations.
• Employee Assistance Program: Support for personal and professional challenges.
• Wellbeing and Engagement: Dedicated teams to support your wellbeing.
• Family-Friendly Policies: Supportive policies for a balanced work-life.
• Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.
• Development Opportunities: Coaching, mentoring, educational programs, and formal training.
• Subsidized Canteen: Enjoy meals at a reduced cost.
• Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
Locations
Bray, Ireland
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time