POSITION: Supplier Quality Auditor
DEPARTMENT: Quality Assurance
REPORTING TO: Senior Manager, Supplier Quality
LEVEL: P3
LOCATION: Cork
PURPOSE OF JOB
The post holder will provide experience and technical guidance in the Supplier Quality function and be responsible for overseeing contract manufacturing organisations and service providers to ensure McKesson private label products are manufactured and distributed compliance with internal procedures, FDA and Health Canada regulations. The post holder will participate as a team member monitoring supplier activity to ensure compliance, manage risk and minimise supply interruptions across McKesson private labels including Strategic Sourcing Services LLC (SSSL); Northstar Rxllc and McKesson Corporation dba SKY Packaging
KEY RESPONSIBILITIES
1. Supplier & customer relationship management: building mutually beneficial relationships with suppliers and internal customers fostering a partnership approach to risk management
2. Perform quality audits of contract manufacturing facilities, including, but not limited to Rx, OTC, Dietary Supplement, Device and Sterile finished drug product manufacturing facilities to ensure compliance with cGMP and quality agreements
3. Perform quality audits of third-party service providers to ensure compliance with regulatory and contractual requirements
4. Perform responsible sourcing audits of contract manufacturing facilities as per company guidelines
5. Partner with colleagues to enhance departmental audit processes
6. Assist in the development of audit programs including implementation of audit productivity tools
7. Assist in the development and implementation of supplier quality risk management tools
8. Work collaboratively cross functional teams to ensure oversight results clearly communicate the identified risks/exposures to business unit and executive level management
9. Interprets quality and regulatory issues and recommends solutions and best practices
10. Negotiation, execution and maintenance of supplier quality agreements
11. Generation and maintenance of supplier scorecards
12. Operate within the Quality Management System across all SQ related activities
13. Support McKesson Enterprise Quality initiatives
14. Coach other team members to succeed in accordance with I2CARE and ILEAD principles
15. Foster a culture of learning and engagement, empowering technical judgement and decision making
16. A source of technical guidance and support to individuals, teams, and senior leadership
REQUIREMENTS:
Education/Training:
Educated to degree level or higher, minimum B.Sc. (biological or chemical sciences) or B. Eng,
(process and chemical)
Experience:
4+ years pharmaceutical manufacturing experience in a regulated facility
Broad knowledge of at least one manufacturing dosage form
Experience of laboratory, with considerable expertise in at least one dosage form
Knowledge and Skills:
17. Pharmaceutical auditing experience preferred
18. Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment
19. Solid understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
20. Experienced in risk management tools and techniques
21. Demonstrated ability to lead suppliers to improve performance; including the ability to influence through effective communication and diplomacy
22. Ability to work independently and make decisions based on judgement and integrity
23. Proven analytical skills and ability to transfer findings into well written report formats
24. Ability to work effectively with others to accomplish goals
25. Demonstrates and understands customs and beliefs of various groups or cultures
26. Experienced in operating under a Quality Management System
27. Strong communication and interpersonal skills
28. Effective team building ability
29. A continuous improvement mindset
Work Environment/Physical Demands:
Hybrid working model with the ability to work from home and in the general office environment. International travel up to 30% of the time to meet business needs.
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
€48,700 - €81,100