Senior QA Systems Manager
Postuler
locations: Inverin, County Galway, Ireland
time type: Temps plein
posted on: Offre publiée aujourd'hui
job requisition id: R5650380
About Viatris
Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie.
The Role & What You Will Be Doing
The Senior Quality Assurance (QA) Manager has responsibility for administration of the Quality Management System at Mylan Teoranta (A Viatris Company), with responsibility to ensure products are manufactured according to all applicable regulatory and corporate guidelines. The Senior QA Manager is responsible for the day to day management of the QA department, identified as the Management representative per the requirements of ISO 13485: 2016; 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 Assurance Manager role will make an impact:
* Responsible for the overall management and administration of the Quality Assurance Department.
* Responsible for the overall administration of the Quality Management System (QMS) at Mylan Teoranta.
* Responsible for the management and engagement of all Team Leads within QA.
* Responsible for site Inspection Readiness including the preparation, handling and responding to quality system audits of the site by regulatory authorities, corporate auditors or customers.
* Responsible for the management of the site Complaint Handling process, site Document Control process, Vendor Management process.
* Responsible for the management and implementation of the relevant impact assessments for the purpose of assessing New & Revised Standards.
* Responsible for management of the site Change Control process (both temporary and permanent changes).
* Responsible for management of the site Deviation management / Non-Conformance (Incident Report) & CAPA process.
* Support new product introduction to the site and new product launches as required ensuring the QMS processes are considered and can cater for quality oversight to ensure a robust compliance framework.
* Provide Quality leadership and technical guidance as required to all personnel at the site. Drive a culture that ensures quality and continuous improvement is central with positive impact on site KPIs, whilst ensuring team well-being is monitored and managed.
* Demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable quality outcomes.
* Stay abreast of changing requirements/expectations and proactively address within the quality system. Implement appropriate solutions that address complex technical, legal and global regulatory standards.
* 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 set objectives that will increase their knowledge and skills level.
* Assist with the departmental budget process and ensure periodic reviews are completed for continuity.
* Attract, retain and proactively develop a pipeline of key talent in the Quality Assurance Organization through coaching, training, experience development and internal/external recruitment.
About Your Skills & Experience
* Minimum of a 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 degree /MEng (or equivalent) in a related discipline and a minimum of 5-10 years relevant experience within a sterile pharmaceutical manufacturing facility and / or Medical Device, Combination Product manufacturing.
* Experience of all quality system aspects in relation to sterile pharmaceutical/medical device manufacturing, including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification.
* 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.
* Must possess extensive exposure to Health Authority (FDA, HPRA, etc) and Notified Bodies (DEKRA, NSAI, etc).
* Excellent communication (both oral & written), interpersonal and presentation skills with a hands-on approach to team leadership.
* Demonstrated strong people management skills.
* Candidates should be self-motivated with the ability to work on their own initiative and should possess excellent organisational and time management skills with the ability to handle multiple tasks in a fast-paced environment.
* Candidates should demonstrate innovative capacity and out of box thinking abilities and be able to apply lean / 6-Sigma practices within the QMS.
* Candidates must be comfortable with reporting to Key Stakeholders at and above site at Global level.
* It is highly desirable that the incumbent is an SME in CAPA & Critical Investigations for Quality Systems.
Benefits at Viatris
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life.
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