Manager, Plasma Quality Assurance

Role Summary

The Quality Assurance (QA) Manager ensures consistent quality of production by developing and enforcing cGMP systems to ensure compliance with operating procedures and regulatory requirements, and reports the facility's compliance status to Operational and Quality management. This role has primary responsibility for the QA release of plasma product shipments and manages the daily activities of the Plasma Logistics Center (PLC) quality assurance staff. Location: City of Industry, CA.

Responsibilities

• Manages the daily activities of the PLC quality assurance staff and ensures that required activities are performed 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 and quality feedback 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.
• Interacts with facility management and other members of PLC management to assure understanding of audit findings.
• Analyzes and evaluates reports prepared by facilities in response to audits performed. Evaluates adequacy of corrective actions, completeness of report and close audits when satisfactorily completed.
• Monitors Plasma Operations to maintain compliance with all applicable regulations, domestic and international. Participates in internal audits of the PLC facility.
• Leads activities to assess facility compliance with SOPs and applicable regulatory agencies (FDA, EMA) and federal/state regulations. Coordinates and conducts Internal Audits at the PLCs.
• Participates in writing and revision of policies and procedures related to the PLC.
• Monitors the PLC to maintain compliance with all applicable regulations.
• Hires quality assurance staff and implements training programs, creates career advancement objectives, conducts performance appraisals, and enacts corrective actions up to termination as needed.
• Meets quality assurance and company financial objectives by monitoring department costs.

Qualifications

• Experience: Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred.

Skills

• 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.
• Ability to make sound decisions that may affect the quality, purity or efficacy of a drug product.
• Anticipates and identifies problems; analyzes situations; considers alternatives; monitors 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.

Education

• BS degree in Biology, Chemistry or related Science or Engineering.