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Associate Director, Quality Monitoring & Validation

Location: 

CA-Los Angeles, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  172810

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

The AD, Quality Monitoring & Validation is an office based position. It will be based in either our RTP, NC or LA office

 

Provide leadership, expertise, support, and direction in the areas of Quality Analytics,  Supplier Quality and Validation.  Manage, develop, and implement Quality / Validation programs and procedures to ensure appropriate regulatory requirements, company standards, and industry practices are met.  Responsible for the development and direct oversight of associates for the achievement of the company’s goals.

 

  • Provide management direction and oversight to the Quality Analytics, Supplier Quality and Validation teams
  • Oversee and maintain an effective validation program that meets applicable industry and regulatory standards, including providing oversight of development of validation protocols for equipment and application software
    • Specifically, lead a team that contributes to validation of existing and new processes and equipment and software.
    •  Specifically, lead a team that deals with compliance-related issues as it pertains to validation activities.
  • Oversee activities and provide leadership for the establishment and maintenance of metrics (KPIs, QUINTET, etc.) and tracking and trending processes to include monitoring organizational performance by gathering relevant data and producing statistical reports
    • Specifically, lead a team that manages and administers the company’s' Key Performance Indicator, Quality Investigation Tool for Evaluating Trends, Spot Audit process, compliance and supplier data trending.
  • Oversee activities and provide leadership to the team responsible for management of supplier quality to ensure suppliers meet the standards set forth by procedures and regulations
    • Specifically, lead a team that manages supply and supplier qualifications, deviations,  investigations, quality agreements and general interactions with third party supplier and vendors, and within Grifols companies.
  • Oversee Data Integrity project to ensure compliance to relevant procedures and regulations
  • Involvement and collaboration with other corporate Quality functions such as risk assessment, deviation management, etc., to contribute to a holistic quality program
  • Direct and oversee evaluations to determine the effectiveness of the supplier quality, analytics and validation programs
  • Direct and oversee the evaluation of regulatory inspection and internal audit findings relating to the supplier quality, analytics and validation programs and develop associated corrective and preventive actions (CAPAs).
  • Oversee the development and revision of Standard Operating Procedures (SOPs) relating to equipment qualification, process validation, quality analytics and supplier quality.
  • Manage budget and administer department funds; develop, monitor, and report department and organizational key performance indicators (KPIs)
  • Provide support to projects identified to support process improvement and business objectives
  • Manage, develop and lead activities of managers and specialists, including work duties, adequate training, development plans
  • With collaboration with Senior Director, routinely provide guidance to center and/or business unit leadership for routine and/or complex validation, quality analytics and validation issues/questions
  • Oversee and develop the teams to continuously improve the impact the department has on the overall organization

 

EXPERIENCE & EDUCATION

  • Bachelor's Degree in science or a related field required.
  • Requires a minimum of 8 years of experience working in a corporate quality, regulatory affairs, or validation role. Project or technical leadership experience required. Supervisory or management experience preferred. 
  • Strong working knowledge of current Good Manufacturing Practice regulations, donor center SOPs, and validation principles.  Excellent quantitative and analytical skills.  Excellent problem solving skills and communication skills (i.e., verbal, written, and electronic).  Ability to successfully interface with all levels of management and customers or suppliers in various functional modalities to assure a consistent supply of quality goods and services.  Highly developed skills in leadership, negotiation, and influence.  Ability to successfully interface with individuals from scientific, production, regulatory, and executive management backgrounds to achieve quality and business goals and objectives.  Detailed knowledge of all relevant regulatory and guidance requirements, as it relates to validation and supplier quality GMP practices. 

Occupational Demands Form # 5:  Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Occasionally walks.  Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25 lbs.  Frequently drives to site locations with occasional travel within the United States.  Position may require routine travel up to 25%.  Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.  Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.  Ability to apply abstract principles to solve complex conceptual issues.

 

EEO Minorities/Females/Disability/Veterans

 

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Location: NORTH AMERICA : USA : CA-Los Angeles || NORTH AMERICA : USA : NC-RTP:USHOME - Home Address 

 

Learn more about Grifols

 


Nearest Major Market: Los Angeles