Senior Quality Operations Manager page is loaded
Senior Quality Operations Manager Solicitar locations Inverin, County Galway, Ireland time type Tiempo completo posted on Publicado hoy job requisition id R5658877 Mylan Teoranta
En VIATRIS, vemos la atención médica no como es, sino como debería de ser.
Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.
Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.
Lo hacemos a través de:
Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias; Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente; Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience.
Viatris is more than just a place to work.
This is a place to make a difference in the world.
The Role & What You Will Be Doing Senior QA Manager will support Senior Quality Leadership by providing systematic overview of the sites compliance and state of control through management of the site self-inspection program and by providing support to the site incident report (CAPA) system.
The role requires an active partnership with the Senior Quality Assurance Manager & relevant Compliance leads in transforming the site quality system to support the site to ensure that high standards of GMP are maintained at all times.
The role reports directly to the Senior Director QA and where relevant is the nominated designate.
Every day, we rise to the challenge to make a difference and here's how the Senior Quality Operations Manager role will make an impact:
Manage the site compliance and quality systems.
Manage the day-to-day management of Quality Management System in compliance with GMP and appropriate global and site policies and procedures, such as Complaints, CAPA, Deviations and Change Control, and global improvement programs for product Quality.
Allocate resources based on the quality system priorities and corresponding business needs.
Establish high standards for performance management and accountability to achieve quality and organizational objectives.
Assign project work and review workload for all direct reports.
Assist staff with their responsibilities, establishing goals and setting objectives that will increase their knowledge and skills level.
Manage training programs to ensure quality oversight and a robust compliance framework.
Attract, retain, and proactively develop a pipeline of key talent in the Quality Assurance Organization through coaching, training, experience development, and internal/external recruitment.
Manage the Quality Risk Management process per the requirements of ISO 14971:2019.
Assist with the departmental budget process and ensure periodic reviews are completed for continuity.
Establish the site GEMBA process in line with changing infrastructure requirements.
Demonstrate commitment to high standards of GMP compliance and product quality.
Interface with site operation owners to collect and analyze key data related to Quality Metrics as required.
Provide Quality leadership and technical guidance to all personnel at the site.
Drive a culture that ensures quality and continuous improvement are central, with positive impacts on site KPIs, while ensuring team well-being is monitored and managed.
Assist & coordinate site Inspection Readiness, including preparation, handling, and response to quality system audits by regulatory authorities, corporate auditors, or customers.
Perform other duties as assigned to adapt to changing business needs.
About Your Skills & Experience For this role, we're looking for a candidate with an effective combination of the following qualifications, skills, and experiences:
Bachelor's degree (or equivalent) in a science or engineering-related discipline and a minimum of 10 years relevant experience within a sterile manufacturing facility at management level, or an MSc / MEng degree (or equivalent) with 5-10 years relevant experience within a sterile pharmaceutical manufacturing facility and/or Medical Device, or Combination Product manufacturing.
Extensive knowledge of Pharmaceutical and Combination Product Process Quality.
Use of Lean principles is desirable.
Good working knowledge of applicable standards and regulations for sterile manufacturing, including but not limited to Annex 1, ICH210, 211, 21 CFR 820, Part 4 & Part 11 Compliance.
Excellent communication (both oral & written), interpersonal, and presentation skills with a hands-on approach to team leadership.
Strong people management skills demonstrated.
Self-motivated candidates with the ability to work independently, possessing excellent organizational and time management skills to handle multiple tasks in a fast-paced environment.
Innovative capacity and out-of-the-box thinking abilities, with the ability to apply lean / 6-Sigma practices within the QMS.
Comfortable reporting to Key Stakeholders at global levels.
Highly desirable: SME in CAPA & Critical Investigations for Product Quality.
At Viatris, we are committed to building a diverse, inclusive, and authentic workplace.
If you're excited about this role but your experience doesn't fully match every requirement, we still encourage you to apply.
You may be the right candidate for this or other roles.
Why Viatris?
We offer competitive salaries, benefits, and an inclusive environment to utilize your experience, perspectives, and skills to make an impact.
Opportunities for career progression and work-life balance initiatives are also available.
Diversity & Inclusion at Viatris We value diversity and inclusion as essential to our mission.
To learn more, visit
Sustainability at Viatris Our corporate social responsibility efforts aim to promote responsible and sustainable operations, empowering people to live healthier lives at every stage.
Learn more at
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