Manager, Quality​/Sr. Manager, Quality; QA Fractionation

Manager, Quality / Sr. Manager, Quality (QA Fractionation)

Location:

NC-Clayton, US

Contract Type:
Regular Full-Time

Area: TECHNICAL

Schedule:

Day Shift

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.

Responsible for managing all aspects (i.e. quality systems, release, documentation, laboratory operations, compliance, training, staffing and budgetary needs, etc.) of the Quality Assurance Fractionation Business Unit.

• Manages all aspects of the QA Fractionation Business Unit (quality systems, overall compliance, oversee department budget, employee relations, etc.).
• Follows cGMP and department safety practices.
• Provides guidance as well as consult with manufacturing, maintenance, logistics, and internal regulatory departments on GXP matters.
• Uses expertise and sound judgment to make independent decisions within defined areas of responsibility.
• Plans and analyzes workflow, delegate and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget.
• Participates in regulatory inspections/customer audits including providing written responses as applicable for area of responsibility.
• Practices high level of facilitations skills to reach consensus and works toward solutions.
• Review and revise Standard Operating Procedures and generate reports.
• Investigates and initiates corrective actions for quality related issues.
• Collaborates and efficiently communicates to internal and external customers.
• Applies quality risk‑based processes to seek continuous improvement of systems, processes, and facilities.
• Provides effective leadership to employees in the Quality Assurance Fractionation Business Unit.
• 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).
• Provides Quality support, reviews and approvals of regulatory labeling and submissions.

In addition to the duties described above the QA Manager provides QA support of NFF and NFB pooling and fractionation processes. These processes include pool record review and release, shipment of pool samples to EU regulatory authorities for testing and approvals, review and release of intermediate shipments to contract customers as well as intermediate shipment receipts from other Grifols manufacturers. Responsibilities may include roles such as document author/reviewer or approver in the administration of quality systems such as Change Control, Discrepancy Management, Intermediate Quarantine, pool and fractionation Batch Record review, documentation, SAP Master Data, and Annual Product Reviews as well as provide Quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.

Responsible for representing QA Fractionation at manufacturing business unit meetings, and project meetings .

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. Ability to perform methodical, risk‑based analysis of situations and propose improvements. Good organizational skills are a must and ability to follow up on items to completion in a timely manner.

• Manager, Quality – PhD in a 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 a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, technology, engineering, math, or computer science) with minimum of 8 years…