Sr. Quality Associate I, Compliance

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary:

This position entails performing routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, providing compliance guidance and support throughout the Quality organization, training delivery, and leading multi-departmental teams and initiatives. To ensure success as a Sr. Quality Associate, Compliance, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical   experience preferably in manufacturing, quality assurance, and/or GMP auditing and demonstrated project management experience in leading cross-functional teams.

 

Key Responsibilities:

• To ensure success as a Sr. Quality Associate, Compliance, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing and demonstrated project management experience in leading cross-functional teams.
• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assisting in implementing Internal Audit plans for all Grifols manufacturing plants including Grifols Therapeutics.
• Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants including Grifols Therapeutics.
• Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses.
• Peer Review of Audits Reports.
• Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keeping abreast of industry standards and regulations.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
• Contribution to the continuous improvement of the Quality Management System is required.
• Other additional duties may be assigned by the Manager, Quality Audits from time to time if required.
• Ability to travel (up to 30%)

  

Skills and Abilities

Skills: 

• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Effective influence management and conflict resolution abilities.
• Highly developed investigative and reporting skills.
• Effective organization and time management skills.
• Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups. 

 

Abilities:   

• Ability to travel. (up to 30%)
• Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
• Flexible, able to adapt quickly to change in a fast-paced environment

 

Knowledge & Skills:

Essential:

• Minimum Bachelor’s degree in a scientific discipline.
• Minimum of 3+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing
• ASQ Certification as a Quality Auditor, Manager or Engineer a plus.

• Superior knowledge of U.S. cGMPs and FDA guidance.
• Superior knowledge of EU GMPs, Annexes and ICH Guidance’s and International Standards (Risk Management, ICH 8, 9, 10)
• Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.

 

Desirable:

• Experience in SAP
• Experience in sterile manufacturing

 

 

Occupational Demands:

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.   Frequently walks.  Occasionally bends and twists neck.  Light to moderat