Grifols · 1 day ago
Manager, Plasma Quality Assurance
North Carolina, United States
Full-time
Onsite
Mid, Senior Level
5+ years expGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. The Quality Assurance (QA) Manager is responsible for ensuring consistent quality of production by developing and enforcing good manufacturing practices (cGMP) systems and overseeing the quality acceptance and release of plasma product shipments.
BiotechnologyHealth CareManufacturing
Responsibilities
Manages the daily activities of the PLC quality assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of lookback alerts, quarantine of unsuitable units, and release of source plasma for further manufacture or sales
Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release
Maintains the PLC deviation management system to notify plasma collection centers (internal and external) of nonconformities noted during the plasma receipt and plasma processing
Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints
Participates in the writing and revision of policies and procedures related to the PLC
Monitors the PLC in order to maintain compliance with all applicable regulations
Hires quality assurance staff and implements training programs, career advancement objectives for quality assurance staff, performs performance appraisals and enacts corrective actions as needed to and including termination
Meet quality assurance and company financial objectives by monitoring department costs
Qualification
Required
BS degree in Biology, Chemistry or related Science or Engineering
Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals
Project or technical leadership experience required
Strong analytical, organizational and interpersonal skills
Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia/ICH and ISO Guidelines
Excellent written/verbal/leadership skills
Must be able to make sound decisions that may affect the quality purity or efficacy or a drug product
Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner
Displays a commitment to quality in terms of people, product and processes
Computer literate, with experience in use of Microsoft applications
Preferred
Supervisory or management experience preferred
Benefits
Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase