Assistant Manager of Quality

Responsibilities

• 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 principles, self-inspection learnings, non-conformity discovery, and appropriate remediation.
• Prepare regular reports to center, area, and corporate quality management regarding the state of quality and systems at the center.
• Manage site Quality Control program, including but not limited to calibrations management, monitoring 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. Motivate staff through education to high levels of competency in a dynamic and regulated environment.
• Recruit, hire, conduct performance reviews, and enact corrective actions—up to and including termination—upon proper review with center and quality management.
• Participate with management to develop programs and methods to streamline center processes, improving customer/donor service, product yields, and financial results while maintaining compliance and quality.
• Receive and provide feedback to staff on observations to improve adherence to GMP standards. Report concerns or deficiencies to area personnel and/or management immediately and recommend remedial actions for audit observations and non-compliance issues.
• Lead and function as the key quality representative for site supplier, customer, and regulatory audits. Coordinate remediation (CAPA) and ensure timely closure of audits using quality tools and applications.
• Maintain a clean, efficient work environment and ensure sufficient operating supplies and forms. 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 employees. Communicate effectively with HR to ensure compliance.
• Comply with all federal, state, and local regulatory and company policies and procedures.
• Notify the ADOQ for any event negatively affecting the safety, quality, identity, purity, or potency of the product, resulting in pausing or disruption of business. Escalate notifications to Regional Director, Associate Director of QA, Divisional Director, or Director of Quality Systems and Assurance if necessary.
• Maintain confidentiality of all personnel, donor, and center information. Understand policies and procedures associated with hyperimmune programs at the center if applicable.
• Lead investigations into deviations to determine root cause, correction/preventative actions, and effectiveness checks. Monitor CAPAs and effectiveness checks to ensure issues are resolved.

Qualifications

• Bachelor’s degree in a scientific discipline/life sciences or related field.
• 5+ years of experience related to quality and regulatory affairs, preferably in the Plasma industry.
• Demonstrated leadership/supervisory experience.
• Knowledge of government and industry regulations.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.