Quality Control Senior ManagerCork, Ireland Job ID JR0091410 Category Quality Assurance Post Date May. 25, 2023
POSITION: Quality Control Senior Manager
REPORTING TO: Senior Director of Quality
DIRECT REPORTS: 6
PURPOSE OF JOB
The post holder will provide leadership and technical guidance in the Quality Control function and be responsible for managing QC activities including laboratory testing to ensure McKesson private label products are tested, accepted or released in compliance with internal procedures, FDA and Health Canada regulations. The post holder will lead a team managing QC activities in related disciplines to ensure compliance, manage risk and minimise supply interruptions across McKesson private label.
- Management of a team of specialists evaluating technical data, setting direction, deploying resources to support distribution decisions for McKesson private label products
- Development of risk and mitigation strategies on the storage and transport of finished drug products
- Supplier relationship management: building mutually beneficial relationships with suppliers to turn regular business interactions into long-standing partnerships
- Collaborate with key stakeholders in mitigating supply interruptions through timely evaluation and resolution of quality related incidents Release of SKY Unit Dose re-packaged private label products for US distribution
- Approval of batch manufacturing records for SKY re-packaged products, providing assurance of compliance with CGMPs and US FDA regulations
- Approval of release testing as performed via contract service providers for re-packaged private label products
- Responsible for a stability programme supporting shelf life of re-packaged private label product
- Management of Annual Product Quality Review reports for re-packaged private label products
- Oversight of multiple service provider contracts performing QC and re-packaging activities
- Provide batch screening and new product launch support to McKesson Canada (Sivem) private label, specifically for NorthStar sourced products
- Support New Product Launch processes for McKesson US Private Labels
- Oversight of a laboratory function ensuring efficient sampling, shipment, and testing programmes
- Collaborate with the US QA and Operations Manager contributing to the release for distribution process within the NSDC, Northstar Distribution Centre
- Fiscal responsibility for capital and resource requirements within the Quality Control Laboratory to assist in budget preparation and ongoing cost management.
- Operate within the Quality Management System across all QC related activities
- Support McKesson Enterprise Quality initiatives
- Recognise team strengths, development needs and professional goals
- Coach team members to succeed in accordance with I2CARE and ILEAD principles
- Foster a culture of learning and engagement, empowering technical judgement and decision making
- Assist direct reports in establishing Individual Development Plans to expand their knowledge and skill set
- A source of technical guidance and support to individuals, teams and senior leadership
(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)
Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline.
9+ years regulated experience in pharmaceutical Quality Control, preferably in a progressive multinational organisation. This experience should include a minimum of +4 years laboratory experience. 1+ years people leadership experience
Knowledge and Skills:
- Proven track record of sound judgement and decision-making capabilities in a QC/QA environment
- Competent influencing skills with a demonstrated ability to achieve results through others
- Demonstrated strategic thinking and planning skills
- Solid understanding of cGMP as applied to pharmaceutical manufacturing
- Comprehensive understanding of Drug Product testing requirements in multiple dosage forms
- Competent background in analytical method development and decision making
- Extensive knowledge of pharmaceutical stability testing
- Detailed knowledge of Good Laboratory Practice
- Awareness of Data Integrity, ISO-17025 and Computerised System Validation requirements
- Confident in data management systems
- Experienced in operating under a Quality Management System
- Strong communication and interpersonal skills
- Effective team building ability
- A continuous improvement mindset
MS Office; Knowledge of Lab CDS and statistical packages is desirable, MasterControlTM, BADU (Internal)
Work Environment/Physical Demands:
Hybrid working model with the ability to work from home and in the general office environment. International travel may be required occasionally to meet business ne
At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.
As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Our Base Pay Range for this position€66,800 - €111,300
How we work and live plays a big role in building a healthier world. View our wide range of health benefits, financial benefits, wellness programs, and flexible working schedules.
Ready for the next step? We’ll guide you along the journey of our hiring process.
Culture and Values
Advancing health outcomes for all — this is the foundation of how we interact with customers, business partners, and each other. Meet the team and learn more about our mission.
Diversity, Equity & Inclusion
Our culture is built around diverse perspectives because everyone’s unique story, experiences, and ideas are valued here.
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