Manager, Quality Audits

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.

Manager, Quality Audits:

Position Summary:
This position is part of the global GWWO Auditing Department & entails performing routine GMP audits as well as speciality 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 Manager, Quality Audits, 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. The successful candidate will have people reporting in from other locations.

Key Responsibilities:
•    To ensure success as a Manager, Quality Audits, 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 within North America.
•    Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants within North America.

•    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 and approval 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 Director Quality Audits from time to time if required.
•    Ability to travel (up to 30%)

Key Competencies 
Skills:  
•    Strong interpersonal skills.
•    Excellent written and verbal communication skills.
•    Effective influence management and conflict resolution abilities.
•    Highly developed investigative and reporting skills.
•    Effective organisation 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.

Qualifications
•    Minimum Bachelor’s degree in a scientific discipline.
•    Minimum of 5+ 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 
•    Previous experience in managing teams