Assistant Manager of Quality

CSL; Colorado Springs (CO); Vor Ort; USD 70.000 - 77.000; Vollzeit

Zusammenfassung

CSL Vifor in Colorado Springs seeks a QA leader to ensure center readiness by enforcing SOPs and the quality system, managing CAPA, and driving continual improvement in a regulated plasma environment.

The role guides staff through performance reviews, corrective actions, and regulatory inspections, while coordinating with HR and center leadership to maintain compliance and high-quality outcomes.

Qualifikationen

• 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.

Aufgaben

• Maintain center readiness by enforcing SOPs, quality system adherence and CAPA.
• Manage site Quality Control program including calibrations, sampling, KPI tracking and trend analysis.
• Lead and develop staff to ensure QA competency; recruit, hire, review performance and take corrective actions up to termination.
• Collaborate with management to streamline processes for improved service, yields and financial results while maintaining compliance.
• Lead supplier, customer and regulatory audits; coordinate remediation and ensure timely audit closures.
• Maintain safe, compliant work environment and ensure availability of forms; promote Health, Safety and Environment practices.
• Adhere to HR policies and ensure center management compliance with HR.
• Ensure compliance with all regulatory and company policies; report significant quality events to leadership.
• Lead investigations into deviations, determine root cause and implement corrective actions; monitor CAPA effectiveness.

Kenntnisse

Leadership experience

Quality management

Regulatory knowledge

Ausbildung

Bachelor degree in life sciences

Jobbeschreibung

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.

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

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

The expected base salary range for this position at hiring is $70,1000 - $76,600. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.