Assistant Manager of Quality (Bilingual – English/Spanish)

CSL; Loíza (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

CSL is seeking a Quality Assurance leader to ensure the center remains inspection ready by enforcing SOPs, quality systems and regulatory compliance. You will lead the QA team, manage calibration programs, KPIs, CAPA and audits, and partner with management to improve customer service, yields and financial results while maintaining safety and regulatory standards.

You will drive investigations, report findings to corporate quality management, recruit and develop staff, and uphold HR, HSE and OSHA

Qualifications

• Bachelor’s degree in scientific discipline or life sciences.
• 5+ years’ experience related to quality and regulatory/plasma industry experience.
• Demonstrated leadership/supervisory experience.
• Knowledge of government and industry regulations.

Responsibilities

• Ensure center is inspection ready by managing SOPs, quality system compliance and remediation.
• Manage site Quality Control program including calibrations, sampling, KPIs, trend analysis and CAPA.
• Lead and develop staff to maintain QA competency; recruit, review performance and take corrective actions.
• Collaborate with management to streamline center processes for improved service, yields and financial results.
• Provide feedback to staff on GMP adherence and report non-conformities promptly.
• Lead audits for supplier, customer and regulatory entities and coordinate CAPA closures.
• Maintain safe, clean work environment and ensure HSE/OSHA compliance.
• Ensure HR policies are followed and center management adheres to HR compliance.
• Notify ADOQ of events affecting safety or product integrity as required.
• Lead investigations into deviations and monitor CAPA effectiveness.

Skills

Leadership / supervisory experience

Regulatory knowledge

Quality systems understanding

Audit coordination

Education

Bachelor's degree in scientific discipline/life sciences or related discipline

Job description

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 as to the state of quality and systems at the center.
• Manage site Quality Control 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.
• 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 of 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 timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation.
• Maintain clean efficient work environment and ensure 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 ensure center management is doing the same.
• Comply with all federal, state and local regulatory and company policies and procedures.
• Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance.
• Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable.
• Lead investigations into deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved.

Qualifications

• Bachelor degree in scientific discipline/life sciences or related discipline
• 5+ years' experience related to quality and regulatory/ Plasma industry experience
• 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.