RBW are partnering with a well-established CDMO to present a Vice President, Quality position. 

With over 60 years industry experience, the CDMO have recently secured funding are excited to expand their sites across US and Europe. With a focus on Sterile Manufacturing but also operations in formulation and development, lyophilization optimization, global regulatory support, and secondary packaging. This is an opportunity to collaborate with an ambitious and complex pipeline on a Global scale. 

With oversight of operations across Europe and US, you'll be heavily involved in Quality Strategy and Clinical/Commercial operations. 

Responsibility: 

• Maintaining the company aware of all global regulations that may impact the Global operations
• Establishing a surveillance process for all deficiencies & observational themes surging in the global regulatory environment.
• Managing the Regulatory Affairs teams in US and Europe
• Maintaining up to date all Drug Master Files of the company and collaborating with clients to keep their submissions up to date.
• Establish & Manage all communications with regulatory agencies
• Perform Quality & Compliance Internal corporate Audits.
• Interact with the Product Development groups to manage and submit all regulatory filings for customer as well as internal needs.
• Help redact and review responses to Regulatory bodies that had conducted audits at our sites.

 Requirements:

• Minimum of 12 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 10 years in clinical and or commercial quality operations.
• Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to parenteral drug products.
• Strong knowledge of current industry trends and ability to use the latest technologies.
• Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.
• Strong leadership skills with the ability to thrive in a high throughput environment.
• Ability to lead and manage projects/teams within corporate objectives and project timelines.
• Appreciation and desire to operate within a completely digital GMP environment.
• General knowledge of Quality Systems and compliance
• Greater than 10 years experience in the field