McKesson Quality Systems Manager in Munster, Ireland
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payors, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. We believe in the importance of strong, vital organizations because we know that patients can only be healthy when our system is healthy.
Every single McKesson employee contributes to our mission—by joining McKesson you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
We understand the importance of a system that works together. Your expertise, drive and passion can help us improve everything we touch, from providers to payors to pharmacies. Join our team of leaders to begin a rewarding career.
Wherever you contribute here at McKesson, you will have the ability to make a real impact in the lives of others.
Job Title: Quality Systems Manager
The primary responsibility of this role is to develop and manage the Northstar Healthcare (NH) quality systems function. The post holder will have responsibility for the NH quality system as it applies to NH and NH’s outsourced activities. NH maintains the quality system for the NorthStar group of companies and the post holder shall be expected to work with the Quality Director and the Quality Manager from the other NorthStar site to ensure effective and compliant process, systems and tools are in place to support the end to end business needs and their continuous improvement.
Responsible for managing and reporting on thequality systems and tools within NH including: deviation, change control management,CAPA, rsk management, document control and records management systems at NH.
Develop and refine quality processes andNorthStar’s electronic QMS to meet business needs and continuousimprovement.
Co ordinate quality metrics and management reviewmeetings. Actively participates in the meetings and follow up on actions.
Responsible for ensuring systems are in place toensure NH maintain compliance with quality and technical agreements andregulatory expectations.
Manage the system for internal audits of theNorthStar group and ensure timely compliance.
Ensure readiness and manage external audits of the NH qualitysystems.
Manage a system for training for all NH personneland the delivery of GMDP training.
Set up and manage mock recalls and assist theQuality Director in the set-up and/or running of recall activities.
Ensure a process is in-place for approval,oversight and management of outsourced services.
Co-ordinate quality change control approvals fromcontract manufacturers.
Create & maintain a culture of quality &continuous improvement throughout the organisation.
Assist inthe preparation of quality and technical meetings and prepare reports andmetrics as required by the business.
Oversee and provide direction to the QualitySystems personnel.
Work closely with the management team to supportthe growth and development of NorthStar.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description
B.Sc. Degree in Science or equivalent; a quality qualification while not a requirement is a distinct advantage.
Minimum 6yrsexperience in a progressive pharmaceutical/healthcare industry and preferably with4 years in a quality role.
Proven management experience.
Full understanding and knowledge of cGMP, qualityAssurance and regulatory principles in a pharmaceutical manufacturingenvironment.
Excellent knowledge of US and European regulatoryrequirements.
Experience in managing Quality Assurance and qualitysystems in FDA and HPRA based Pharmaceutical manufacturing essential.
Strong knowledge of pharmaceutical manufacturingin at least one dosage form.
Proven auditing skills while not a requirementare an advantage.
Ability to manage and direct the cross-functionalquality function team
Excellent knowledge of quality management systems.
Strong communication skills with ability tocommunicate at all levels within the Organisation.
Proven analytical skills and problem solvingskills.
Technical writing ability and strong presentationskills.
Ability to work effectively with others toaccomplish goals.
Ability to explore options and make appropriatechoices to support the business.
Understanding of customs and beliefs of othergroups or cultures is an advantage.
An understanding of relevant directives,standards, policies and guidelines and the ability to implementappropriately is also required.
Excellent organisational skills and attention todetail.
A self motivated and results orientatedindividual with the ability to meet deadlines.
Proven project management skills.
Knowledge of computer system validation while notessential is advantageous.
MS Office; knowledge of Quality tracking software is desirable.
General office environment with international travel including Asia, US and Europe.
Organization: McKesson Corporate
Title: Quality Systems Manager
Requisition ID: 17005162