Supplier Quality Auditor

at  McKesson

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.
POSITION: Supplier Quality Auditor
DEPARTMENT: Quality Assurance
REPORTING TO: Senior Manager, Supplier Quality

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:

• Pharmaceutical auditing experience required
• Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment
• Solid understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
• Experienced in risk management tools and techniques
• Demonstrated ability to lead suppliers to improve performance; including the ability to influence through effective communication and diplomacy
• Ability to work independently and make decisions based on judgement and integrity
• Proven analytical skills and ability to transfer findings into well written report formats
• Ability to work effectively with others to accomplish goals
• Demonstrates and understands customs and beliefs of various groups or cultures
• Experienced in operating under a Quality Management System
• Strong communication and interpersonal skills
• Effective team building ability
• A continuous improvement mindset
• Biologics/Biosimilars manufacturing/auditing experience desirable

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

• Supplier & customer relationship management: building mutually beneficial relationships with suppliers and internal customers fostering a partnership approach to risk management
• 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
• Perform quality audits of third-party service providers to ensure compliance with regulatory and contractual requirements
• Perform responsible sourcing audits of contract manufacturing facilities as per company guidelines
• Partner with colleagues to enhance departmental audit processes
• Assist in the development of audit programs including implementation of audit productivity tools
• Assist in the development and implementation of supplier quality risk management tools
• Work collaboratively cross functional teams to ensure oversight results clearly communicate the identified risks/exposures to business unit and executive level management
• Interprets quality and regulatory issues and recommends solutions and best practices
• Negotiation, execution and maintenance of supplier quality agreements
• Generation and maintenance of supplier scorecards
• Operate within the Quality Management System across all SQ related activities
• Support McKesson Enterprise Quality initiatives
• Coach other team members to succeed in accordance with I2CARE and ILEAD principles
• Foster a culture of learning and engagement, empowering technical judgement and decision making
• A source of technical guidance and support to individuals, teams, and senior leadership