Daniel D. Email & Phone Number

Des Moines, Iowa, Estados Unidos

Michoacán De Ocampo, México

Michoacán De Ocampo, México

-Management directly of 4 Heads (Production,Quality, Planning and Process Improvement) and a headcount with a total of 75 employees.-Responsible for all Quality, Production, Process Improvement operations relating to the site for the manufacturing of biological vaccines and biotechnology sterile products.-Take on the ownership, directly and indirectly of key quality systems, driving compliance and continuous improvement onto production process.-Ensuring the compliance and application for all manufacturing activities in accordance with relevant regulatory codes, product registration dossiers, and in line with organization’s Quality Manual.-Supporting and at times leading significant investigations to provide an efficient and effective service to support the timely and compliant disposition of materials, components and products.-Play as a key leadership role in site leadership team ensuring that the site operates in a fully compliant manner in accordance with the relevant corporate governance requirements (including reporting), policies, procedures and guidelines.-Partners with and supports other sites and functions as required.-Acts as the primary site representative for compliance inspections of the site-Participate in and where required lead escalation and issue resolution processes relating to significant regulatory or quality events that require concurrence above site.-Provide leadership and coaching to both quality and production staff in relation to quality performance and continuous improvement.

-Provide advisory on projects for the Pharmaceutical Industry, Government Affairs and Market Access for the worldwide clients on the animal and human health industry of the GLG group.

-Provide advisory on projects for the Pharmaceutical Industry for the worldwide clients on the animal and human health industry.

Área Metropolitana De Guadalajara, México

-Management of the QMS.-Manage the Document Management System.-Manage of the Deviations System.-Manage the Risk Management System.-Manage the System of Complaints, recall, customer service and sales.-Management the System of Internal and External Audits.-Management of the RAP System.-Management of the Change Control System.

Guadalajara, Jalisco, México

-Manage of 50 personnel, divided on 3 groups: Sterile process, Intermediate product and Final product.-Staff training in cGMP, GLP and current regulations (national and international).-Responsible for the production of purified antigens based on cell culture and chicken embryo.-Responsible for the lyophilization and emulsification process and aseptic filling line.-Comply and follow up the production program.-Comply with the equipment maintenance and calibration program.-Control of materials and supplies for production.-Strategic planning, line balancing and production processes.-Monthly and annual budget compliance.-Attention to internal and external audits (MX, USDA, EU cGMP).-Preparation of monthly reports of production lines.-Upstream and downstream of biotechnological processes.-Member of the worldwide committee on Boehringer Ingelheim for aseptic process.

-Manage of the Quality Control laboratories (Microbiology, Chemical, Virology and Animal Testing).-Manage the equipment calibration and maintenance program.-Administration of the Budget of the laboratory and follow-up to CAPEX.-Follow-up to the validation of analytical methods program.-Follow-up to the stability program.-Follow-up to external audits carried out to suppliers and third party.-Comply with internal and corporate KPIs of the company.-Leader of the Subcommittee of Biological Risk Analysis.-Staff training in cGMP, GLP and current regulations (national and international).

-Implementation of new technologies on the laboratory.-Analysis of intermediate and finished product.-Comply with internal and corporate KPIs of the company.