Assistant Manager of Quality

CSL; Salt Lake City (UT); On-site; USD 85,000 - 120,000; Full time

Job summary

CSL in Salt Lake City is seeking a senior QA leader to uphold GMP/GLP standards, oversee the quality program, and drive CAPA, audits, and regulatory compliance.

The role requires leading a team, addressing non-conformities, reporting to quality management, and partnering with HR for training and staffing to meet regulatory requirements. A Bachelor’s in life sciences and 5+ years in plasma quality are required.

Qualifications

• Bachelor degree or higher in a scientific discipline relevant to quality/regulatory roles.
• 5+ years of experience in quality and regulatory fields, preferably in plasma/biopharma.
• Demonstrated leadership and supervisory experience with a track record of team development.

Responsibilities

• Ensure center is inspection ready by adhering to SOPs, policies and quality system.
• Manage site Quality Control program including calibrations, sampling, KPIs, trending and KPI analysis.
• Lead and develop direct reports, recruit, conduct performance reviews and take corrective actions up to termination.
• Collaborate with management to streamline center processes for better service, yields and financial results.
• Lead audits and CAPA remediation, ensuring timely closure of findings and documentation.
• Maintain a safe, compliant work environment and follow HR and regulatory policies.

Skills

Quality and regulatory experience

Leadership experience

Regulatory knowledge

Plasma industry knowledge

Education

Bachelor degree in scientific discipline/life sciences or related discipline

Job description

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