The Role

Lead the development and deployment of quality processes and communications with the assigned region; drive quality culture, competent decision-making, appropriate risk assessments, and timely remediation of situations. Maintain frequent and open communications with executive and corporate leaders that focus on timely resolution of issues that may potentially affect the safety, quality, identity, purity, and/or potency of collected plasma. Review and monitor Quality metrics and reports for trends and opportunities for improvement.

Reports To: Sr. Director, Quality Assurance
Direct Reports: Assistant Manager of Quality (Approximately 6-7)

RESPONSIBILITIES

• Manage staff, including selecting, training, developing, coaching and terminating, as applicable with guidance from Human Resources. Appraise employee performance and provide feedback and counseling to staff, as applicable.
• Manage compliance to and successful use of the Quality System tools such as change and deviations management.
  Ensure regular management review of quality performance that delivers stable, high levels of compliance performance in assigned QA areas. Provide leadership and coordination to established automated systems for control.
• Manage Key Performance Indicators (KPIs) performance to ensure meeting regulatory and departmental requirements, and to drive continual improvement in department processes. Works with CSL applicable systems to analyze and identify significant quality issues/trends and reports those to appropriate Sr. Management. Provides routine reports on the quality KPIs as requested by the applicable business units.
• Maintain understanding of all policies and procedures. Participate in and may lead the development of functional policies and SOPs for assigned areas
• Establish, implement and ensure timely delivery of strategic Quality Assurance performance. Provide direction and guidance on quality topics including resolutions and corrective actions. Perform LSW above center visits. Ensure deployment and sustainability of in-center LSW practices to assigned region.
• Develop & maintain process to disseminate quality interpretation & strategies to operationalize relevant regulations, guidance & standards in collaboration with stakeholders. Maintain & update Quality training materials and provide consistent technical guidance to the operations team. Develop, deploy and occasionally deliver Quality information/publications to appropriate Corporate or Center staff.
• Mentor others on data analysis, technical problem prevention and resolution, design control procedures, investigation processes, and methods to arrive at true root causes as it relates to quality systems.
• Maintain high level of regulatory, compliance and communications skills with department staff, ensuring competence to make decisions and judgments in the course of business, including times of uncertainty.
• Perform other duties, as assigned, to support business needs.

Education

• Bachelor’s Degree in Science, Business Administration or Quality Management required; or
• Minimum 8 years equivalent combination of education, training and experience
• Fluency in English/Spanish

Experience

• 5+ years’ experience successfully serving in a leadership role within an FDA-regulated or other regulated industry required
• Minimum 2 years managing people preferred
• Experience in leading projects to a successful conclusion
• Understand regulatory standards, various local, state, and federal laws that apply to the business and where to find information on standards and interpretations
• Computer literate with knowledge of word processing and spreadsheets
• Excellent critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues, and resolve recurring defects
• Strong leadership, training, written and verbal communication, and interpersonal and presentation skills to drive results
• Organizational skills and ability to manage projects involving multiple tasks by a team with deadlines.
• Good leadership and people management skills are essential in the success of leading project teams.
• Establish solid working relationships with to interface with and support senior management, third parties and other positions and circumstances within the organization
• Excellent customer service orientation with flexibility and adaptability to work as a member of the team and respond quickly to changes as required by the business operations
• Maintain a professional demeanor and handle confidential information with discretion
• Lead teams without the benefit of a direct reporting relationship
  

Additional Comments

The person selected for this position will need to live/relocate to Puerto Rico; they will be responsible for above-center quality leadership of all centers on the island.

Working Conditions (physical & mental requirements)

• Ability to make decisions which have significant impact on the department’s credibility, operations and services
• Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations
• Exercise good judgment to refer decisions to management when decisions fall out of the realm of established guidelines
• Overnight travel required up to 50% of the time
• Frequent standing and walking
• Ability to lift or carry up to 25 lbs.
• Fast-paced environment with frequent interruptions
  

Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications

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