Cardinal Health is partnering with a Global leader in Specialty Medicine, to launch a new drug into the US market. In building this organization, we’re looking for exceptional talent.
Accountabilities in this role:
- Responsible for the release of final product beforedistribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
- As the head of the Quality Assurance team, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements
- Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner
- Ensures CAPAs for which the team is responsible are followed and closed within defined timelines
- Must be able to approve temporary deviations but understanding the nature of the deviation content including intermediate steps and make the link with the final product and any regulatory requirement
- Reviews, comments and challenges in an appropriate way, the Product Quality Reviews for the product with the team’s responsibility. In that context, has the knowledge of the production process of the product
- Understands technical/release product issue and evaluate their potential impact on product quality and compliance
- Escalates complex issues to management in a timely manner
- Responsible to manage a small team of employees
- Prioritizes and ensures work is delivered in an efficient way
- Provides daily problem solving
- Represents QA in meeting related to his/her area of responsibility (product tree meeting, deviations, change control, stability planning and review, validations, etc.)
- Performs other duties as assigned
- B.S. degree in Chemistry, Biology, or related science field.
- 5+ years of relevant work experience in Quality Assurance, working with21 CFR 210 and 211 and external Regulatory body regulations.
- Experience leading regulatory inspections is preferred.
- ASQ Certification preferred.
- Experience leading a successful team.
- Must work well with others and understand how to be successful in a Team environment.
- Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
- Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
The primary work environment consists of a manufacturing facility for the production of radiopharmaceuticals. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation.