Quality Operations Director

· Provides direction and oversight of staff responsible for all quality systems.  Provides leadership for organizational and technical issues.  Drives cross site implementation initiatives.  Provides balanced management of quality and compliance risks with business needs.

· Develops and implements strategy for GMP’s compliance for the site.  Participates in company’s strategic plan development forums.  Assures proper use of compliance and safety MAPs.  Assures compliance to all company policies and FDA and any other regulatory agency requirements.

· Partners with General Manager and Leadership Team to set site vision and strategic direction for the organization and to monitor and drive execution.  Assures appropriate site communications.

· Develops and manages budget, organizational structure and business requirements to accommodate business needs and assure meeting company metrics.

· Reviews monthly report of site compliance metrics, ie. rejects, NCRs, First Pass Quality, complaint rate, inspections, headcount, budget, PE plan

· Develops direct staff and mentor key individuals in various organizations.  Assures that appropriate talent pool is developed to support current and future business needs.

· Principle interface with FDA or other regulatory Health Authorities during inspections and inquiries

· Identifies and sponsors PE projects that impact Quality Division and sponsors cross functional business projects and teams, removing barriers to success.



 

CONTACT INFORMATION:

 





Contact Name: Idelisa Figueroa

 Company:

 

Careers, Inc.

Email:

ifigueroa@careersincpr.com

Phone:

(787) 764-2298

Fax:

(787) 764-2530

***We cordially invite all candidates to enter our website www.careersincpr.com in order to learn more about our services, view job openings, register, post their resume, and/or update their information on our online database. ***