Job Title : Quality Affairs Senior Director
Summary : Are you seeking a senior leadership position with a cutting edge pharmaceutical company? I am working with one of America's top manufacturer of injectable pharmaceutical products. With over 40 products in their portfolio as well as a strong pipeline, my client is on an upward trajectory for continued success in the current market. My client is looking for a leader that has experience all aspects of quality and has strong leadership skills. If you are looking for an opportunity that will allow for growth while being in a position to help an innovative pharmaceutical company grow, this may be the position for you!
The Quality Affairs Senior Director will be responsible for :
- Providing leadership and direction focused on quality management systems and compliance and establishing/maintaining performance goals, training plans and feedback including performance plans and reviews.
- Quality management ownership for deviations, CAPA, change control, document control, technical services and external manufacturers.
- Ensuring site wide cGMP compliance in accordance with 21CFR Parts 210 and 211.
- Managing all aspects of regulatory authority inspections and customer/corporate audits, development of responses and execution of required improvements following inspections and audits.
- Providing oversight for review and release of commercial, R&D and clinical study products as well as maintaining/managing communications and cross-functional activities with internal and external customers and regulatory agencies.
- Owning and supporting metrics-based Continuous Quality Improvement activities and KPI through application of statistical methodology.
The Quality Affairs Senior Director should have the following requirements :
- Bachelor's Degree in a Life Sciences discipline, Master's Degree is preferred.
- At least 15 years of progressive experience in pharmaceutical operation and interactions with regulatory agencies.
- Minimum of 10 years leading functional QA, QC, compliance or manufacturing operations.
- Experience working with sterile injectables.
- Expertise across multiple areas including development of quality system requirements for cGMP compliance of pharmaceutical drug production, laboratory facilities, validation for pharmaceutical manufacturing facility.
- Exceptional people and program management skills.
If this sounds like something you would be interested in, please apply!
