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

Manager, Quality / Sr. Manager, Quality (QA Fractionation) Schedule: Day Shift Summary Responsible for managing all aspects (quality systems, release, documentation, laboratory operations, compliance, training, staffing and budgetary needs, etc.) of the Quality Assurance Fractionation Business Unit. Primary Responsibilities 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 and consults 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, delegates and prioritizes to ensure assignments and projects are completed on time and within projected budget. Participates in regulatory inspections/customer audits, including providing written responses as applicable for area of responsibility. Practices facilitation skills to reach consensus and works toward solutions. Reviews and revises Standard Operating Procedures and generates reports. Investigates and initiates corrective actions for quality‑related issues. Collaborates and communicates efficiently with 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 be 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 providing 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. Minimum Requirements Manager: PhD in Life Sciences, Chemical Sciences, or relevant STEM degree with minimum 6 years relevant experience; MS with minimum 8 years; BS with minimum 10 years; at least 2 years supervisory experience. Previous experience with plasma, pools, fractionation and intermediate products is a plus. Sr. Manager: PhD with minimum 6 years relevant experience; MS with minimum 8 years; BS with minimum 10 years; at least 2 years supervisory experience. Previous experience with plasma, pooling, fractionation and intermediate products is a plus. Agency 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. Equal Employment Opportunity Statement 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) Seniority Level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing #J-18808-Ljbffr