Department: Global Quality
Job Title: Senior QA Specialist
Description:
Reporting to the QA Manager, this individual will be responsible for ensuring the timely review and release of small molecule API and Drug Product used in Phase I/II/III clinical trials and in commercialization activities, as well as assisting QA Management with OOS investigations and manufacturing deviations. This individual will be responsible for reviewing and approving SOPs, protocols, etc. and implementing the appropriate level of GMP compliance at ARIAD. This individual will develop and maintain ARIAD’s audit program to ensure compliance with the appropriate Regulations, i.e. FDA, EMEA etc. ; establish a vendor qualification program; conduct internal audits and external audits of ARIAD vendors (i.e. CMOs and CLOs); assist QA Management in developing and implementing GMP training programs and assist QA Management in development and implementation of Quality systems. The ability to mentor and collaborate with cross-functional peers and other staff is essential.
Job Requirements:
- A minimum of 5 years of QA experience in the pharmaceutical or biotech industry.
- Hands-on experience in the GMP manufacturing environment is highly desirable, especially with the review and approval of Manufacturing Batch Records
- Position requires a good working knowledge of the GMP and ICH regulations and how to implement them in practice
- Experience with small molecule drugs and oral dosage forms are a strong plus.
- Position typically requires 10 – 25 % travel, depending on needs.
- Able to work independently and to execute multiple projects in a timely manner.
- Able to work effectively on daily tasks with minimal instruction and supervision.
- Must exercise judgment within broadly defined practices in order to evaluate and implement quality systems.
- strong interpersonal and communication skills (written and oral) are required in order to interact with vendors, third parties and business partners
- Must be able to collaborate effectively and build bridges across organizations and functions.
- Experienced in Microsoft Office applications, Good PowerPoint and Visio skills are a plus
- Bachelors degree, preferably in Chemistry , Life Sciences, or equivalent industry experience
