Mantell Associates is once again partnering with a sensational organisation that thanks to a recent acquisition, has now open an additional opportunity in the West Coast of United States for a Vice President of QA/QC.
This essential figure for the new site will represent the the senior leader and advisor on all quality aspects, from problem solving to creating and implementing quality assurance and quality control systems and processes for the small molecule space.
Create and implement a Quality Management System and the Quality organization needed to execute it.
Will serve as the key liaison on Quality matters with all functions.
Oversee all GMP quality activities and ensures they are governed through key performance metrics and a quality review systems.
Assure that finished products conform to government and company standards and regulatory approvals for clinical and commercial products.
Lead a customer focus approach in the organization.
Provide the overall leadership with respect to recruiting, training, developing, and supervising staff to accomplish quality compliance and goals.
Responsible for establishing department budgets and managing expenditures appropriately.
8+ years’ experience as a QA/QC leader.
8+ years’ experience working in the small molecule space.
BA/BS degree in related science, an advanced scientific degree is desirable.
A strong experience base on global GMP, QA, and QC issues pertaining to biologics is required.
Expertise in CDMOs/CMOs is required.
In-depth knowledge of FDA, EU and International regulations, US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications, and cGMP.
Excellent communication, leadership, and collaboration skills.
Mantell Associates is a specialist Pharmaceutical & Life Sciences headhunting firm working with the most exciting clients in the industry. For more information get in contact with Sofia Furlan on +44 203 3854 7700 or firstname.lastname@example.org if you're looking to hear further details.