Associate Director, GxP Systems Quality

The Associate Director, GxP Systems Quality will be responsible for the governance, control, and administration of the GxP compliance program for software systems used in operational environment of McKesson Medical-Surgical (MMS). Additionally, this role will have oversight of site quality for MMS facilities in the assigned region.

The primary location for this role is Tempe, AZ but candidates located near Denver, Atlanta, Los Angeles, Sacramento or Seattle may be considered per MMS commute distance requirement. This role is remote hybrid with about 40% onsite presence requirement and up to 25% travel component. Relocation assistance will be provided per McKesson policy.

The Associate Director, QA GxP Systems Quality will be responsible for the governance, control, and administration of the GxP compliance program for software systems used in operational environment of McKesson Medical-Surgical (MMS). Additionally, this role will have oversight of site quality for MMS facilities in the assigned region. This role leads a team of 4-5 fte and may have oversight for outside services workers as required for various projects.

KEY ACCOUNTABILITIES:

• Actively engages & communicates with the operations & IT (McKesson Technology) teams to meet & exceed BU & quality objectives related to GxP compliance
• Process owner for computer system validation and responsible to centralize the GxP compliance program for software systems used in MMS Operations
• This individual must lead by influence, be well organized and have excellent oral and written communication skills to effectively interact with internal and external parties
• The Associate Director must ensure MMS business unit's software systems meet & maintain GxP compliance requirements
• Independently work on problems of diverse scope where analysis of quality attributes & metrics requires evaluation of identifiable factors.
• Independently owns CAPAs from initiation to closure
• Contribute to preparation of MDR, FAR, Drug notifications and/or remediation activities
• Utilize data analytics in decision making and proactive planning regarding quality related issues and incidents
• Provide regular KPI reporting & updates to senior leadership
• For the assigned QMS domains, develops Procedures and Policies to ensure adherence to the company's Quality System and Regulatory Standards.
• Liaise with internal stakeholders as a business enabler, regularly communicating to escalate issues and act as a partner in resolution
• Promote the awareness of quality, regulatory, customer and statutory requirements throughout the organization
• Verifies that all processes required to maintain the software systems in a validated state are followed and appropriate documentation is maintained
• Publishes reports documenting errors and compliances issues and recommends potential solutions when appropriate.
• Manage, mentor & develop staff
• Highly visible role, may require evening & weekend engagements during critical situations
• Up to 25% annual travel estimated to support business needs
• Additional duties include supporting quality organization during planned & unplanned events (audits, inspections etc) as needed

KEY RELATIONSHIPS:

• Communicates frequently with stakeholders in HQ functions and Operations to cascade quality issues and successes and to explain/understand new requirements and regulations as they arise
• Partners with Operations & IT Project Workstream Leads to ensure that all quality goals and procedures are in place and working and initiate any risk mitigation
• Frequent interactions with regulatory agency/competent authorities and key suppliers/trade partners
• Partners with the external vendors/suppliers to resolve any ongoing issues related to purchased systems & services

QUALIFICATIONS:

• Undergraduate degree required, MS preferred
• Proficient in FDA 21CFR 820 & ISO 13485 requirements
• 10-12 years of QA experience required, minimum 7 years in a quality leadership role in drugs and/or device industry
• Previous interaction with FDA highly desirable
• Experience with MasterControl or other computerized document control systems a plus
• Good working knowledge and understanding of cGMP, Quality Standards, Requirements, and Specifications (ISO, ANSI, FDA, etc).
• ASQ/RAPS or other related certification required within 12 months of hire

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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. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

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Current employees must apply through the internal career site.

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