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Sr. Principal, Global Quality Systems Business Partner at Eli Lilly and Company
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 19 year(s)
Assistant Manager at Crew Clothing Company
London Area, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Mechanical Design Engineer at Attis Trading Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Senior Accountant at Louis Dreyfus Company
Australia Capital Territory, Australian Capital Territory, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Clinical Operations Specialist at Eli Lilly and Company
England, Londonderry - Northern Ireland, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Execution & Logistics Officer at Louis Dreyfus Company
Queensland, Queensland, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Lead - HR Specialist at Eli Lilly and Company
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 23 year(s)
Customer Success Manager at The Pool Tile Company
dubai, Dubai, Germany - Full Time
Skills Needed
N/A
Senior Accountant at Louis Dreyfus Company
Sydney, Western Australia, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
MSAT Process Specialist / Expert – Formulation and Filling (m/f/d) at Eli Lilly and Company
Germany, Alberta, Germany - Full Time
Skills Needed
N/A
Mitarbeiter Produkttransfer (m/w/d) at Eli Lilly and Company
berlion, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 18 year(s)
Regulatory Affairs Director at Eli Lilly and Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Customer Service Representative at Sigma Company Limited
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Forward Deployed Engineer at The Wonderful Company
holland, North Holland, Netherlands - Full Time
Skills Needed
N/A
Warehouse Manager at Sigma Company Limited
Berlin, Newfoundland and Labrador, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Supplier Quality Inspector at Hyundai Rotem Company
Adelaide, South Australia, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Software Test Team Lead at DTC | A Codan Company
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Manager, IT Infrastructure & Operations at TRYST TRADING COMPANY
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 25 year(s)
Technical Lead (Hardware/Software) at Attis Trading Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Technical Buyer - Hardware & Electronics (Hybrid) at Attis Trading Company
Berlin, British Columbia, Germany - Full Time
Skills Needed
N/A
Sr. Principal, Global Quality Systems Business Partner at Eli Lilly and Company
dublin county, Dublin County, Ireland -
Full Time

Start Date

Immediate

Expiry Date

14 Jan, 27

Salary

85000.0

Posted On

16 Oct, 26

Experience

19 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

About the job

About Astellas


Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .


Are you driven to make a real difference in the lives of patients?


We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.


Working Environment and Location


  • This position is based in Tralee, Ireland.
  • This position requires you to be 100% on site / in the office.

Purpose and Scope


The Quality Assurance Operations role will be primarily responsible for ensuring compliance of all manufacturing activities that form part of the Astellas Ireland Tralee Plant operations. Responsibilities will include establishment of oversight processes in the manufacturing, warehouse and facilities area that ensure compliance with all relevant cGMP regulations. The position will also ensure the ongoing qualification status of all systems in the area. The position will also support the establishment and management of the batch record review process, as well as review of all record types within the quality management system prior to Qualified Person review. The position will be key to facilitating regulatory and customer inspections. The position will make required contributions to team goals, collaboration across all departments and influence key stakeholders.


Role and Responsibilities


  • Quality Systems & GMP: Establish and maintain robust QA processes, batch record review, GMP training, and Quality Management Systems to ensure regulatory compliance.
  • Manufacturing & Compliance Oversight: Provide QA oversight across manufacturing, warehousing, facilities, validation, change controls, specifications, and CMC changes, ensuring commercial readiness is maintained.
  • Audits & Regulatory Readiness: Support regulatory and customer audits, Annual Product Quality Reviews, and ongoing compliance with global regulatory requirements (HPRA, EMA, FDA, PMDA, NMPA, etc.).
  • Cross-Functional Collaboration: Build effective relationships with Plant teams, T&M colleagues, wider QA functions, and other stakeholders to ensure quality requirements are clearly understood and delivered from plant set-up onwards.
  • External Communications: Ensure effective and robust communication with regulatory authorities, other Astellas sites, the wider QA organisation, and relevant industry groups.
  • Leadership & Quality Culture: Champion Quality and Compliance across the Tralee Plant, mentor QA and wider Plant colleagues, and promote a strong, positive quality-focused culture.

Essential Qualifications


  • Science based degree with experience in a cGMP compliance environment in an Aseptic Manufacturing Plant.
  • Experience of supporting regulatory inspections and customer audits.
  • QP Eligibility is desirable

Why Astellas


  • Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
  • Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
  • Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
  • A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours


Integrity


Innovation


Impact


One Astellas


Accountability


Courage


Sense of Urgency


Outcome Focus


Skills And Capabilities


Organizational Focus


Benefits


Careers | Astellas


We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
Responsibilities

About the job

About Astellas


Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .


Are you driven to make a real difference in the lives of patients?


We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.


Working Environment and Location


  • This position is based in Tralee, Ireland.
  • This position requires you to be 100% on site / in the office.

Purpose and Scope


The Quality Assurance Operations role will be primarily responsible for ensuring compliance of all manufacturing activities that form part of the Astellas Ireland Tralee Plant operations. Responsibilities will include establishment of oversight processes in the manufacturing, warehouse and facilities area that ensure compliance with all relevant cGMP regulations. The position will also ensure the ongoing qualification status of all systems in the area. The position will also support the establishment and management of the batch record review process, as well as review of all record types within the quality management system prior to Qualified Person review. The position will be key to facilitating regulatory and customer inspections. The position will make required contributions to team goals, collaboration across all departments and influence key stakeholders.


Role and Responsibilities


  • Quality Systems & GMP: Establish and maintain robust QA processes, batch record review, GMP training, and Quality Management Systems to ensure regulatory compliance.
  • Manufacturing & Compliance Oversight: Provide QA oversight across manufacturing, warehousing, facilities, validation, change controls, specifications, and CMC changes, ensuring commercial readiness is maintained.
  • Audits & Regulatory Readiness: Support regulatory and customer audits, Annual Product Quality Reviews, and ongoing compliance with global regulatory requirements (HPRA, EMA, FDA, PMDA, NMPA, etc.).
  • Cross-Functional Collaboration: Build effective relationships with Plant teams, T&M colleagues, wider QA functions, and other stakeholders to ensure quality requirements are clearly understood and delivered from plant set-up onwards.
  • External Communications: Ensure effective and robust communication with regulatory authorities, other Astellas sites, the wider QA organisation, and relevant industry groups.
  • Leadership & Quality Culture: Champion Quality and Compliance across the Tralee Plant, mentor QA and wider Plant colleagues, and promote a strong, positive quality-focused culture.

Essential Qualifications


  • Science based degree with experience in a cGMP compliance environment in an Aseptic Manufacturing Plant.
  • Experience of supporting regulatory inspections and customer audits.
  • QP Eligibility is desirable

Why Astellas


  • Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
  • Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
  • Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
  • A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours


Integrity


Innovation


Impact


One Astellas


Accountability


Courage


Sense of Urgency


Outcome Focus


Skills And Capabilities


Organizational Focus


Benefits


Careers | Astellas


We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
Sr. Principal, Global Quality Systems Business Partner at Eli Lilly and Company
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 19 year(s)
Assistant Manager at Crew Clothing Company
London Area, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Mechanical Design Engineer at Attis Trading Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Senior Accountant at Louis Dreyfus Company
Australia Capital Territory, Australian Capital Territory, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Clinical Operations Specialist at Eli Lilly and Company
England, Londonderry - Northern Ireland, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Execution & Logistics Officer at Louis Dreyfus Company
Queensland, Queensland, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Lead - HR Specialist at Eli Lilly and Company
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 23 year(s)
Customer Success Manager at The Pool Tile Company
dubai, Dubai, Germany - Full Time
Skills Needed
N/A
Senior Accountant at Louis Dreyfus Company
Sydney, Western Australia, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
MSAT Process Specialist / Expert – Formulation and Filling (m/f/d) at Eli Lilly and Company
Germany, Alberta, Germany - Full Time
Skills Needed
N/A
Mitarbeiter Produkttransfer (m/w/d) at Eli Lilly and Company
berlion, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 18 year(s)
Regulatory Affairs Director at Eli Lilly and Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Customer Service Representative at Sigma Company Limited
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Forward Deployed Engineer at The Wonderful Company
holland, North Holland, Netherlands - Full Time
Skills Needed
N/A
Warehouse Manager at Sigma Company Limited
Berlin, Newfoundland and Labrador, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 9 year(s)
Supplier Quality Inspector at Hyundai Rotem Company
Adelaide, South Australia, Australia - Full Time
Skills Needed
N/A
Experience Required
Minimum 5 year(s)
Software Test Team Lead at DTC | A Codan Company
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
Manager, IT Infrastructure & Operations at TRYST TRADING COMPANY
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Experience Required
Minimum 25 year(s)
Technical Lead (Hardware/Software) at Attis Trading Company
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
Technical Buyer - Hardware & Electronics (Hybrid) at Attis Trading Company
Berlin, British Columbia, Germany - Full Time
Skills Needed
N/A