Senior Director, Quality Assurance & Regulatory Affairs @ McKesson

Job Information

Job Description:

Job Responsibilities:

• Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team
• Developing and Implementing written policies, procedures, and standards of conduct for the overall Quality Assurance program to meet all applicable regulatory requirements (21 CFR Parts 11, 210, 211, 820) for Repackager/Relabelers as well as ISO 9001 and state Board of Pharmacy requirements for 3PL activity.
• Developing effective lines of communication to external and internal customers as well within the organization itself.
• Conducting periodic risk assessments, internal audits, and developing response plans where appropriate.
• Provide Governance on various QARA system elements, utilizing data driven approaches and state of control measurements to identify potential trends and take action accordingly.
• Serve as a key leader in the McKesson 3PL Organization, helping drive positive Quality Culture Values and engaging with leaders of existing and potential clients.
• Responding promptly on detected offenses, developing corrective action, and reporting findings to the VP, Quality and Regulatory Affairs.

The Senior Director, QARA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance and regulatory affairs activities. This enables the Senior Director, QARA the ability to review contracts and obligations (seeking the advice of legal counsel, where appropriate) that allow the Company to comply with all contracted obligations.

In addition, the Senior Director, QARA will be responsible for all internal audit reports and will work closely with key managers to identify trends inconsistent with policies, procedures and contractual obligations. The Senior Director, QARA should ascertain patterns that require a change in policy and forward these issues to the quality assurance committee to remedy the problem.

Typical Minimum Experience

• 13+ years of relevant Quality Assurance and Regulatory Affairs experience
• 5+ years of management experience
• 4-year degree in business or related field or equivalent experience
• Advanced degree a plus (MBA, MS)
• Must be able to travel up to 30-40%

Critical Skills

• 5 + years’ experience working within Quality Assurance in a government regulated environment
• Accreditation experience with ISO Standards or regulatory agencies (DEA, FDA, etc.)
• Must be able to work independently and to be able to make tough and difficult reports when necessary
• Must be detail-oriented, well-organized self–starter with high energy and creativity and ability to adapt to change in a positive manner
• Ability to effectively utilize reference materials
• Excellent oral and written communication skills
• Strategic problem solving and decision-making ability
• Ability to effectively manage conflict
• Computer proficiency in MS Office Suite including intermediate Excel
• Lean Six Sigma highly preferred

Company Information

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