Senior Manager, Quality Puerto Rico

CSL•Puerto Rico, MP

About The Position

The Senior Manager, Quality leads the development and deployment of quality processes and communications for the assigned region. The role drives a strong quality culture, competent decision-making, appropriate risk assessments, and timely remediation. It maintains frequent, open communication with executive and corporate leaders to resolve issues that may affect the safety, quality, identity, purity, or potency of collected plasma. The position also reviews and monitors quality metrics and reports for trends and improvement opportunities. The role provides above-center quality leadership for all CSL Plasma centers on the island of Puerto Rico. The selected candidate must live in or relocate to Puerto Rico and reports to the Sr. Director, Quality Assurance. The position has approximately 6–7 Assistant Manager of Quality direct reports. Overnight travel is required up to 50% of the time.

Requirements

Bachelor’s degree in Science, Business Administration, or Quality Management, or a minimum of eight years of an equivalent combination of education, training, and experience.
Fluency in English and Spanish.
At least five years of successful leadership experience in an FDA-regulated or other regulated industry.
Experience leading projects to successful completion.
Understanding of regulatory standards and applicable local, state, and federal laws, including how to locate standards and interpretations.
Computer literacy, including word-processing and spreadsheet knowledge.
Excellent critical reasoning, decision-making, and problem-solving skills to analyze situations, assess risks, find preventive solutions, and resolve recurring defects.
Strong leadership, training, written and verbal communication, interpersonal, and presentation skills.
Organizational skills and ability to manage multi-task, team-based projects with deadlines.
Ability to establish effective working relationships to support senior management, third parties, and others across the organization.
Strong customer-service orientation, flexibility, and adaptability; ability to work as a team member and respond quickly to operational changes.
Professional demeanor and discretion when handling confidential information.
Ability to lead teams without a direct reporting relationship.
Must live in or relocate to Puerto Rico.
Ability to make decisions with significant impact on departmental credibility, operations, and services.
Ability to formulate complex, comprehensive materials, such as authoritative reports, and/or make formal presentations.
Good judgment in referring decisions to management when they fall outside established guidelines.
Ability to travel overnight up to 50% of the time.
Frequent standing and walking; ability to lift or carry up to 25 pounds.
Ability to work in a fast-paced environment with frequent interruptions.

Nice To Haves

At least two years of people-management experience is preferred.

Responsibilities

Lead the development and deployment of regional quality processes and communications, supporting quality culture, sound decision-making, risk assessment, and timely remediation.
Maintain frequent, open communication with executive and corporate leaders to support timely resolution of issues that may affect collected plasma.
Review and monitor Quality metrics and reports for trends and improvement opportunities.
Manage staff, including selection, training, development, coaching, termination when applicable, performance appraisals, feedback, and counseling, with Human Resources guidance as appropriate.
Manage compliance with and effective use of Quality System tools, including change and deviation management.
Ensure regular management review of quality performance to achieve stable, high compliance in assigned QA areas; lead and coordinate established automated control systems.
Manage KPI performance to meet regulatory and departmental requirements and drive continual process improvement; analyze quality issues and trends using applicable CSL systems, report significant issues to senior management, and provide routine KPI reports as requested.
Maintain knowledge of policies and procedures and participate in or lead development of functional policies and SOPs for assigned areas.
Establish, implement, and ensure timely delivery of strategic Quality Assurance performance; provide direction on quality topics, resolutions, and corrective actions.
Perform LSW above-center visits and ensure deployment and sustainability of in-center LSW practices throughout the assigned region.
Develop and maintain processes for communicating quality interpretations and strategies that operationalize applicable regulations, guidance, and standards in collaboration with stakeholders.
Maintain and update Quality training materials, provide technical guidance to operations, and develop, deploy, and occasionally deliver Quality information or publications to corporate or center staff.
Mentor others in data analysis, technical problem prevention and resolution, design control procedures, investigations, and root-cause analysis related to quality systems.
Maintain regulatory, compliance, and communication competence among department staff, supporting sound decisions and judgments, including in uncertain situations.
Perform other duties as assigned to support business needs.