Regulatory Affairs Specialist jobs in Louisville, KY

The state of healthcare is complex, but our shared purpose isn't: Help people get the medicine they need to live healthier lives. CoverMyMeds solves medication access challenges for patients throughout every step of their journey through a unified brand that now encompasses RelayHealth, McKesson Third Party Logistics, McKesson Prescription Automation and CoverMyMeds.

Job Summary

Our mission at McKesson Third Party Logistics is to help biopharma, traditional pharmaceutical, and medical device companies accelerate access to the supply chain and reduce risk.

It is the responsibility of all team members to read, understand, and comply with all policies and procedures that apply to each specific role. It is the obligation of management, managers, supervisors and team leads to ensure quality assurance and compliance with pertinent regulations, policies, and procedures. Management, managers, supervisors and team leads "own" the responsibility of quality assurance and compliance.

The Senior Director, Quality Assurance and Regulatory Affairs (QARA) collaborates to set policy and procedures and then audits/monitors quality assurance. The Senior Director, QARA is principally responsible for the development and implementation of the Company's quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters. Additionally, the Senior Director, QARA will work closely with and collaborate with the other senior leaders within the Company to provide overall vision, strategy and support of quality assurance initiatives. The focus is on proactive management of quality assurance risks and preventive management as opposed to crisis management. The ideal candidate is a well-spoken, organized, energetic, enthusiastic, and optimistic leader with the ability to work collaboratively with team members, other areas of the McKesson businesses, teams, and clients.

The Senior Director, Quality Assurance and Regulatory Affairs will have direct access to:

• All business units within the Company
• Legal counsel
• Corporate Quality Assurance, Regulatory, and Compliance teams

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

Physical Requirements

• Environment (Office, warehouse, etc.) - remote (home) office
• Travel - requires up to 30-40% travel as needed
• General office demands (standing/sitting)

At CoverMyMeds, 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. For more information regarding benefits at CoverMyMeds, please

As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. 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.

Our Base Pay Range for this position

CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees.Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.