Director, Quality

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.

Company Profile

McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively.

United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more info, visit www.mckesson.com.

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us.

Position Description

McKesson is seeking a Director, Quality.

The Director of Quality Assurance (Change Control and Policies) is responsible for developing, implementing, and sustaining the elements of the quality management system pertaining to Change Control and Policies. This role will ensure that procedures, analytics, and technology are implemented and effectively leveraged to maximize process efficiencies and compliance across 35+ distribution centers.

Key Responsibilities

• Drives and directs the development, implementation, and maintenance of the Change Control Program throughout the Business Unit.

• Engages in the review of draft Enterprise Policies, ensures changes are implemented to accommodate the activities of PSaS, enables the alignment with Enterprise Policies and directs the implementation of key processes and procedures within PSaS.

• Provides expertise and leadership on the activities and quality systems necessary to ensure that PSaS is in full compliance with sound scientific practice, data integrity principles, current Good Manufacturing Practices, as applicable, and standard operating procedures. Influence stakeholders to embrace and comply with the quality strategy.

• Represents Quality on regulatory and customer audits, project teams, quality and business initiatives, investigation processes and related programs. Facilitate corrective actions with respect to audit findings.

• Reviews and approves documentation as applicable, including but not limited to Change Controls, Policies/Procedures, Investigations, CAPA, Quality Agreements and Qualifications/Validations.

• Implements, maintains, and leads continuous improvement of the Quality Management Systems with a focus on Change Control and Policies to minimize quality related issues.

• Promotes a positive working environment by communicating clear direction on the quality strategy.

Education & Minimum Requirements

• Bachelor’s Degree in Life Sciences or Technical Field.

• Typically requires 12+ years of professional experience and 4+ years of management experience. 

Critical Skills

• 12 years professional experience in GxP environment including 4+ years of people management experience.

• Must have working knowledge of drug product regulations.

• Expertise with respe