The Director, Quality & Regulatory Affairs will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site.The site quality head is responsible to ensure that the systems, procedures and practices at the site comply with Piramal policies and the requirements of all major regulatory body agencies (e.g. FDA/Health Canada/EMA, etc).
Role
Developing and implementing a comprehensive quality management system for the OSD site
Ensuring compliance with all relevant regulatory requirements, including FDA and EMA guidelines
Leading and mentoring a team of quality assurance professionals
Overseeing the validation and qualification processes for OSD manufacturing equipment and systems
Conducting internal and external audits to ensure the highest quality standards are maintained
The successful candidate will have a Bachelor's degree in a relevant scientific field, with at least 5 years of experience in pharmaceutical quality management. A thorough understanding of OSD manufacturing processes and regulations is essential.
If you are a dedicated and detail-oriented quality professional looking to make a significant impact in the pharmaceutical industry, we would love to hear from you. Please submit your resume and cover letter detailing your relevant experience and qualifications.