Manager, Quality Audits

GRIFOLS, S.A.•Clayton, NC

13d•Onsite

About The Position

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.

Requirements

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.
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.
Minimum Bachelor’s degree in a scientific discipline.
Minimum of 5+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing.
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.

Nice To Haves

ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
Experience in SAP
Experience in sterile manufacturing
Previous experience in managing teams

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%)