Job Details

Job Description:

McKesson's CoverMyMeds is currently seeking a highly skilled and detail-oriented Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. You will work closely with the Operations team to ensure compliance with regulatory requirements and to maintain the highest level of product quality and safety.

Responsibilities:

1. Quality Assurance Oversight:

- Provide Quality Assurance and Regulatory Affairs oversight for all processes in the Shepherdsville, KY Facility.

- Oversee all Quality Assurance processes, including product release processes, ensuring that each manufacturer's product release process is correctly followed by the quality team in the Shepherdsville DC Facility.

- Ensure that regulatory and operational requirements are defined, implemented, and monitored at the DC.

- Monitor the temperature of all product storage areas and document excursions as per defined processes.

2. Compliance and Training:

- Verify that Operations maintains training records for all associates and that all resources are trained on key Standard Operating Procedures (SOPs) associated with their roles in the Louisville DC Facility.

- Serve as a training resource to ensure compliance with cGMP, PDMA, ISO, and pharmacy laws related to third-party logistics and wholesale regulations.

3. Documentation and Reporting:

- Log all relevant information on site processes, compliance, and issues in the respective quality management systems.

- Lead non-conformance or Corrective and Preventive Action (CAPA) investigations related to product quality.

- Create reports documenting errors and compliance issues and recommend potential solutions when appropriate.

4. Communication and Audits:

- Regularly communicate with the site Operations Team to escalate issues and recognize individual and team compliance.

- Host client audits to ensure compliance with client requirements and cGMP and pharmacy regulations for all services provided, including ISO and other external audits.

5. Project Management and Development:

- Lead pack-out projects to ensure compliance with client and product requirements.

- Assist in the development of new business processes.

- Assist the Senior Manager of QA/RA with special projects.

Requirements:

- Degree or equivalent experience.

- 6+ years of professional experience, with 0-2 years of supervisory experience.

- Strong knowledge of quality assurance principles, practices, and regulatory requirements.

- Familiarity with cGMP, PDMA, ISO, and pharmacy laws related to third-party logistics and wholesale regulations.

- Excellent attention to detail and analytical skills.

- Strong communication and interpersonal skills.

- Ability to work independently and collaboratively in a fast-paced environment.

- Proficiency in documentation and report writing.

- Experience with hosting client audits and managing compliance.

- Project management experience is a plus.

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, pleaseclick here.

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.​