Job Details

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.

The Role

McKesson Global Procurement and Sourcing is seeking a Vice President of Global Quality & Regulatory Operations to lead all activities associated with Quality and Regulatory management for McKesson’s private label generics business, which includes NorthStar, SKY Packaging, Aisling, HealthMart OTC, and SunMark OTC brands.

Based in Cork, Ireland, the leader will lead a quality and regulatory team responsible for the regulatory compliance and quality management activities associated with sourcing and commercializing private label products under the identified McKesson brands. This role is responsible for designing and implementing the overall regulatory strategy, quality assurance program, and Quality Management System (QMS) and ensuring internal adherence to related regulations and guidelines.

The leader will be the main interface to global regulators and quality and regulatory compliance leadership throughout McKesson. He/she is expected to help evolve a risk-based sourcing strategy to meet all regulatory needs while ensuring the highest level of product quality sourcing. The leader and his/her respective team will be tasked with working with global suppliers to improve and exceed cGMP standards of product manufacturing and quality and optimize operating costs associated with the private label supply chain.

Key Responsibilities

• Along with SVP, develop and execute vision, strategy, and capabilities to evolve the Quality Management System (QMS) and associated Regulatory Compliance strategy for the McKesson global private label business
• Drive the generics private label quality and regulatory strategy while partnering with the enterprise quality management team and other key quality and regulatory stakeholders
• Collaborate closely with senior leaders to evolve the private label value proposition to enhance value for customers and patients through the leveraging of compliant quality and regulatory strategies
• Ensure that the business’s SOPs, work instructions, job descriptions, and training documentation are current, relevant, and appropriately maintained
• Accountable for developing and executing the regulatory strategy, and for managing interactions with the U.S. FDA regulatory authorities with respect to all regulated products including prescription and OTC products
• Continuously improve the quality and regulatory systems and processes that govern the operations including but not limited to quality control systems, audit and risk identification systems, regulatory monitoring, etc.
• Demonstrate knowledge of requirements and processes to compliantly maintain products on the market, including reporting and surveillance responsibilities
• Adept at assessing project risks, and where appropriate, recommend contingency plans and strategies to mitigate risks
• Knowledge of applicable domestic and international laws, regulations, and guidance that affect prescription drug and OTC products
• Cultivate an engaged culture that inspires and motivates the organization to deliver exceptional results while advancing key talent within the organization
• Drive a culture of continuous improvement while fostering talent development and learning by proactively coaching and assisting the team, providing relevant education and training sessions, and developing and sharing interpretations of FDA guidance and other pertinent regulatory issues

Qualifications

• 15+ years of relevant business experience, including pharmaceutical manufacturing and associated quality/regulatory systems
• 10+ years of leadership and commercialization experience, including sales and operations
• 10+ years of experience with generic pharmaceutical manufacturer environments

Education

A bachelor’s degree in business or a related field is required; an advanced degree is preferred.

Physical Requirements

• General office demands
• Must have the ability to travel globally up to 50% of the time

#LI-DNI

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. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.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