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Quality Assurance Assistant Manager
The Quality Assurance Assistant Manager position is responsible for managing the realization of Good Manufacturing Practices (GMP) performance at the assigned Center business. Partners 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. Leads the 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. Leads investigations to determine root cause, corrective/preventative actions, and appropriate coordination/leadership of process improvements. Proactively facilitates communication and interdepartmental coordination quality issues and hosts audits.Main Responsibilities and Accountabilities:Ensures the 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, selfinspection learnings, nonconformity discovery and appropriate remediation. Prepares regular reports to Center, Area and Corporate Quality management as to the state of Quality and systems at the Center.Manages the 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.Leads and develops direct reports ensuring they are competently skilled to perform their QA roles, Leads by example, consistently motivates 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, recruits, hires, conducts performance reviews and enacts corrective actions as needed up to and including termination.Participates 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 raises ideas for consideration for change locally and upwards to Quality and Area management.Receives and provides feedback to staff on observations leading to improved adherence to GMP standards. Reports concerns or deficiencies to area personnel and/or area management immediately. Makes recommendations for remedial actions to resolve audit observations and other noncompliance issues or deficiencies.Leads and functions as the key Quality Representative for site supplier, customer and regulatory audits. Leads the Center's review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilizes Quality tools and applications to facilitate understanding of issues and documentation.Maintains clean efficient work environment, and ensures sufficient operating supplies and availability of forms, as needed. Complies with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conducts routine audits of internal procedures and documentation, as necessary. Promotes safety in all actions.Adheres to all HR policies and practices through fair and equitable treatment of all employees. Communicates effectively with HR to ensure HR compliance and ensures that center management is doing the same. Complies with all federal, state and local regulatory and company policies and procedures.Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. Maintains confidentiality of all personnel, donor and center information. Understands the policies and procedures associated with hyperimmune programs at the center if applicable. Performs other duties as assigned.Qualifications and Experience Requirements:Bachelor's degree in management, biological sciences, Quality or related major or equivalent combination of relevant work experience and education required. Certification by a recognized Quality organization such as the American Society for Quality or the ability to obtain certification within 6 months of accepting position.Minimum 5 years of related work experience required, including a minimum 2 years of experience in a medical or regulated environment in a Quality or Management capacity. Demonstrated successful experience with cGMP and applicable CFR required.Proven ability to communicate effectively through verbal, written and demonstration instructions and procedures ensuring clarity and understanding. Must demonstrate customer service skills and the ability to work effectively with the public.Possess excellent supervisory, management, and delegation skills. Must have solid analytical capability and ability to handle multiple priorities and tight deadlines. Must have the ability to communicate internally throughout the entire organization, and externally to outside personnel.Must be trained successfully in all Center areas within 6 to 12 months in this position. Must be proficient in Microsoft Office products, and able to perform basic math calculations.In depth knowledge of all applicable regulations such as Food & Drug Administration (FDA) and German Health Authority (GHA), and standards such as Plasma Protein Therapeutics Association (PPTA).