QA Manager/Sr. Manager (QA Final Container Release)

GRIFOLS, S.A.

1d•Onsite

About The Position

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 / Sr. Manager, Quality (QA Final Container Release) Summary: Responsible for managing all aspects (batch release, documentation, compliance, training, staffing budgetary needs, etc.) of the Quality Assurance Final Container Release group. Primary responsibilities for role: Manages all aspects of the QA FC Release group (batch release, documentation, compliance, training, staffing budgetary needs, etc.). Consults with manufacturing, logistics, regulatory affairs, and Grifols sister sites on batch release matters. Uses expertise and sound judgment to make independent decisions regarding product batch release and systems. Plans and analyzes workflow, delegates and prioritizes to ensure that batches are released in a timely manner to meet company goals and market demand. Investigates and initiates corrective actions for batch release related issues. Provides effective leadership to employees in the Quality Assurance FC Release group Reviews and revises Standard Operating Procedures and generate reports. Participates in regulatory inspections/customer audits including providing written responses as applicable for FC Release related topics. Applies quality risk-based processes to seek continuous improvement of release systems and processes. Practices high level of facilitations skills to reach consensus and works toward solutions. Collaborates and efficiently communicates with internal and external customers Demonstrates high levels of value and integrity. Demonstrated skills in managing projects to bring in on budget, on schedule, and technically correct (Sr. Manager level). Acts as the site Recall/Withdrawal Coordinator. Follows cGMP and department safety practices. In addition to the duties described above the QA Manager must have excellent communication skills (written and verbal) and extensive working knowledge of applicable regulations (i.e. U.S. Food and Drug Administration, Eudralex, Health Canada) and other applicable regulatory agency requirements/guidelines. They must be able to perform methodical, risk-based analysis of situations and propose improvements. They must have good organizational skills and a demonstrated sense of urgency and ability to follow up, in a timely manner, on items until completion. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton Learn more about Grifols

Requirements

Manager, Quality - PHD in Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 6 years relevant experience. MS in Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 8 years relevant experience. BS in Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 10 years relevant experience. At least 2 years of previous supervisory experience is also required. Demonstrated proficiency in SAP/SAP QM is a plus
Sr. Manager, Quality - PHD in Life Sciences, Chemical Sciences, or relevant (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 6 years relevant experience. MS in Life Sciences, Chemical Sciences, or relevant (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 8 years relevant experience. BS in Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 10 years relevant experience. At least 2 years of previous Supervisory experience is also required. Demonstrated proficiency in SAP/SAP QM is a plus.

Nice To Haves

Demonstrated proficiency in SAP/SAP QM is a plus

Responsibilities

Manages all aspects of the QA FC Release group (batch release, documentation, compliance, training, staffing budgetary needs, etc.).
Consults with manufacturing, logistics, regulatory affairs, and Grifols sister sites on batch release matters.
Uses expertise and sound judgment to make independent decisions regarding product batch release and systems.
Plans and analyzes workflow, delegates and prioritizes to ensure that batches are released in a timely manner to meet company goals and market demand.
Investigates and initiates corrective actions for batch release related issues.
Provides effective leadership to employees in the Quality Assurance FC Release group
Reviews and revises Standard Operating Procedures and generate reports.
Participates in regulatory inspections/customer audits including providing written responses as applicable for FC Release related topics.
Applies quality risk-based processes to seek continuous improvement of release systems and processes.
Practices high level of facilitations skills to reach consensus and works toward solutions.
Collaborates and efficiently communicates with internal and external customers
Demonstrates high levels of value and integrity.
Demonstrated skills in managing projects to bring in on budget, on schedule, and technically correct (Sr. Manager level).
Acts as the site Recall/Withdrawal Coordinator.
Follows cGMP and department safety practices.