Job Description
Mc Kesson is a Fortune 10 company that touches virtually every aspect of healthcare. This role is a key part of ensuring quality care and delivering insights, products, and services. The Supplier Quality Auditor will oversee contract manufacturing organisations and service providers to ensure Mc Kesson private label products are manufactured and distributed in compliance with internal procedures, FDA and Health Canada regulations. **Key Responsibilities:** * Manage relationships with suppliers and internal customers to foster a partnership approach to risk management * Perform quality audits of contract manufacturing facilities, including Rx, OTC, Dietary Supplement, Device and Sterile finished drug product manufacturing facilities to ensure compliance with c GMP and quality agreements * Perform quality audits of third-party service providers to ensure compliance with regulatory and contractual requirements * 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 * Collaborate with cross-functional teams to ensure oversight results clearly communicate identified risks and exposures to business unit and executive level management * Interpret quality and regulatory issues and recommend solutions and best practices * Negotiate, execute and maintain supplier quality agreements * Generate and maintain supplier scorecards * Operate within the Quality Management System across all SQ related activities * Support Mc Kesson Enterprise Quality initiatives * Coach other team members to succeed in accordance with I2 CARE and ILEAD principles * Foster a culture of learning and engagement, empowering technical judgement and decision making * Provide technical guidance and support to individuals, teams, and senior leadership **Requirements:** * Educated to degree level or higher, minimum B. Sc. (biological or chemical sciences) or B. Eng, (process and chemical) * 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 * Solid understanding and knowledge of c GMP, 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 **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 * Comprehensive benefits to support physical, mental, and financial well-being * Competitive compensation package determined by performance, experience and skills, equity, regular job market evaluations, and geographical markets