Director, Quality
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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 respect to investigation and change control systems as well as the ability to drive the development, implementation, and enforcement of processes and procedures to assure quality.
Detailed knowledge of FDA, DEA, State BoP, and other regulatory agencies.
Deep knowledge of wholesale distribution and/or pharmaceutical manufacturing.
Additional Skills
Excellent influencing, collaboration, and communication skills to direct the business unit on quality related issues with leadership.
Ability to work on multiple projects and flexibility to adapt to changing priorities.
Must possess strong organizational/planning skills as well as strong problem solving and decision-making skills.
Working Conditions
Able to travel overnight domestically 25% of the time.
Remote/Work at Home – Must live in proximity to a McKesson Distribution Center in one of the following states: AK, AL, AZ, CA, CO, FL, GA, IA, IL, MA, MI, MO, MS, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA & WA.
Must be authorized to work in the US unrestricted – This position is not eligible for sponsorship.
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. 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. For more information regarding benefits at McKesson, please
Our Base Pay Range for this position
$128,500 - $214,100
- Location:
- Us
- Job Type:
- FullTime