Quality Assurance Assistant Manager

This position is responsible for managing the realization of Good Manufacturing Practices (GMP) performance at the assigned Center business.

Collaborate with center management to ensure compliance with all relevant regulations, laws, standards and Company policies, and that the Center is "inspection ready" at all times.

Lead quality team to ensure all staff is competently performing their duties as evidenced by findings of a program of monitoring, tracking and trending of key metrics.

Responsible for hiring, retention and development of quality staff

Lead investigations to determine root cause, corrective/preventative actions, and appropriate coordination/leadership of process improvements.

Proactively facilitate communication and interdepartmental coordination quality issues and hosts audits.

Main Responsibilities and Accountabilities:

Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality Assurance (QA) principles, self-inspection learning, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.

Manage site QA program including but not limited to calibrations management, monitoring of compliance to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs)), trending and analysis of KPIs, root cause and failure mode impact assessment, and change management.

Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination.

Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. Working knowledge of the change management process and appropriately raise ideas for consideration for change locally and upward to quality and area management.

Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues or deficiencies.

Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilize quality tools and applications to facilitate understanding of issues and documentation.

Maintain clean efficient work environment, and ensures sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions.

Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensures that center management is doing the same.

Comply with all federal, state and local regulatory and company policies and procedures.

Ensure accurate donor data recording in the electronic donor information management system, per the SOPs.

Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper-immune programs at the center if applicable.

Qualifications and Experience Requirements:

Bachelor's degree in business administration, biological sciences, or quality program or equivalent combination of education, training and experience required

Certification by a recognized quality organization such as the American Society for Quality preferred

Minimum 2 year supervisory experience or minimum 4 years in a leadership position required in a medical, quality, or regulated environment preferred, or completion of CSL Plasma leadership development program

Experience with cGMP and applicable CFR preferred

Must have had experience with quality auditing

Excellent critical reasoning, decision-making, and problem solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects

Strong organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives

Strong leadership, training, written and verbal communication, and interpersonal and presentation skills to drive results

Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations

Proven skills in budgeting and financial management preferred

Leading, developing and managing employees preferred

Intermediate working knowledge of Microsoft Office products

CSL Plasma is an EEO/AA Employer