This position leads a team of colleagues with a wide range of validation and compliance responsibilities.
These responsibilities include but not limited to
> Tech Transfer;
> Product and Process Validation;
> Audits and Inspections;
> Site Change Management Program;
> Cleaning Validation;
> Equipment Qualification;
> Packaging Validation
> Equipment and Process Validation: the incumbent is responsible for the overall validation organization and all aspects of validation for equipment process and products at the site.
> Tech Transfer - consists of a manager and a team of professionals who support every product and transfer project at the site. These projects arise from many separate processes, including continuous improvement projects, and business. The incumbent will develop close communication channels with each of these various project sources.
> Audits and Inspections – assurer that compliance validation and data integrity requirements are met. Provides necessary advice and expertise during audit and inspection
> Product and Process Validation - includes a manager and a team of professionals who support all product and process validation at the site while following industry contemporary and Pfizer Quality Standards.
> Site Change Management Program - a team of professionals that are responsible for keeping the validated status of finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.
> Cleaning Validation - consists of a manager and a team of professionals to ensure that all cleaning processes are qualified, and that products process of being enhanced are validated appropriately.
The successful candidate will provide strategic and tactical support to the managers and professionals in all of the following areas: equipment and process validation, packaging and cleaning validation, compliance, current GMP, Regulatory/CMC, deviation investigations related to validation activities. The candidate will also maintain appropriate contacts to access additional information in regards to the overall pharmaceutical compliance landscape.
He or She will be also responsible for the development, mentoring, and performance management of a team, professionals, and technicians.
This position is responsible for maintaining the structure to ensure that all internal and regulatory commitments and timelines are tracked and met. In addition, resource projections and budget preparations are expected. Also responsible to provide or oversee the preparation of project cost estimates.
Education and Experience
> BS/MS or PhD in Chemistry, Biochemistry, Engineering, Pharmacy or related science;
> At least 10 years in the Pharma industry and minimum 5 years of direct experience in validation;
> The candidate should have experience in at least several of the following: GMP, Regulatory (world wide), deviation investigation, technical product transfers, and product and process validation;
> Experience in sterile injectables manufacturing is preferred;
> Previous experience as a manager of colleagues is required and experience leading first line supervisors is preferred;
> The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
> The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities;
> To perform this job successfully, an individual should have an advanced knowledge of MicroSoft Office (Word, Excel, Outlook, Access, and Projects);
> Fluent English is required. Italian knowledge is preferred.