Senior Quality Assurance Associate
Dublin, Leinster Job ID R0175301 Category Quality Subcategory Quality Business Unit Global Manufacturing & Supply Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Senior Quality Assurance Associate
Purpose:
Provide independent and strategic Quality Assurance oversight for the compliant manufacture of API, Drug Product, and Finished Product. Ensure alignment with cGMP, regulatory expectations, and Takeda quality standards. Act as a key QA SME, accountable for leading complex quality decisions, managing QMS elements (deviations, CAPAs, change controls, risk assessments), and driving inspection readiness and continuous improvement initiatives. Embed a proactive quality culture across operations with high autonomy and GMP judgement.
Reports directly to the QA Executive, supporting prioritisation and delegation of QA activities, coordinating workload distribution, and ensuring timely execution of site quality deliverables. The senior associate acts as delegate to the QA Executive when required, supporting decision-making, task prioritisation, and continuity of QA oversight in their absence.
How will you contribute:
Documentation and Batch Review
- Review and approve executed batch manufacturing records, cleaning records, and analytical data.
- Review and approve master batch records, validation protocols/reports, and other GMP-controlled documents associated with the product lifecycle.
- Perform Quality on the shop floor activities to facilitate manufacturing & quality standards.
Quality System Support
- Oversee and support QMS elements relevant to manufacturing, including change controls, CAPAs, deviations, risk assessments, and quality agreements.
- Oversees QMS effectiveness and ensures alignment with site, global, and regulatory quality standards.
Inspection and Audit Readiness
- Support regulatory and partner audits relating Drug Product, API and API intermediate manufacture.
- Drive proactive inspection readiness by ensuring data integrity, timely documentation, and audit trail compliance.
- Leads audit preparation, SME responses, and interaction with auditors/inspectors.
Continuous Improvement and Leadership
- Identify and implement quality and compliance improvements related to transfer activities and site-wide systems.
- Champion Takeda’s core values (Takeda-ism) and foster a culture of quality and compliance across cross-functional teams.
What you bring to Takeda:
Education
- Leaving certificate or equivalent (Minimum)
- Third level (or equivalent) qualification in chemistry, biology, pharmacy, or a related life science discipline are an advantage.
Experience
- Minimum 3–5 years’ experience within the pharmaceutical or biopharmaceutical industry.
- Demonstrated experience in Quality operations.
- Strong knowledge of GMPs.
Skills & Competencies
- Proven ability to work cross-functionally on projects with minimal supervision.
- Exercises QA judgement on deviations, change controls, and quality risks with regulatory awareness
- Strong decision-making, problem-solving, and risk assessment capabilities.
- Excellent communication and stakeholder management skills, with ability to influence across departments of the organisation.
- Acts as QA SME, managing stakeholders across functions and escalating issues when needed.
- Proficient in writing and reviewing technical documentation, including batch reports and investigation summaries.
- Skilled in using electronic quality systems (e.g. TrackWise, Veeva, LIMS).
General Expectations :
- Foster a culture of safety, compliance, and continuous improvement.
- Lead by example in timely completion of training, documentation, and SOP adherence.
- Participate in and contribute to internal and external audits, safety initiatives, and cross-functional projects.
- Mentor junior QA staff and maintain standards of training.
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!
