Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
Regulatory Compliance: (15%)
Stays current with federal, state, local and company-specific rules, regulations, and practices.
Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
Plasma Collection Center Quality Assurance Oversight: (80%)
Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the District Quality Manager.
Responsible for oversight of the plasma shipment process and is authorized to stop/hold shipment if product may be compromised. May stop operations when donor or product safety is or may be compromised.
Identifies potential SOP revisions as needed to support continuous improvement.
Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations.
Tracks responses to and evaluates effectiveness of corrective actions for errors.
Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
Coordinates management review meetings and participates in center staff meetings.
Employee Recruitment and Retention: (5%)
Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases.
Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively.
Provides timely feedback on performance and initiates disciplinary action when necessary.
Participates in the evaluation and review of center staff.
Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Minimum of one year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable.
Previous work experience within the plasma collection industry is strongly preferred.
Computer skills in word processing, excel, data analysis and databases highly desirable.
Demonstrated understanding of quality assurance in an FDA-regulated environment.
Demonstrated understanding of plasma center operations.
Effective organizational, technical and problem solving skills.
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Refers to Group/District Manager for guidance on complex, high-impact or urgent decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
Consults and coordinates directly with the Center Manager on quality concerns within the plasma center.
Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience.
Attend staff meetings and other team meetings as required.
Attention to detail and ability to work independently
Effective coaching and counseling skills.
Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
May participate in the management of projects and new initiatives within the center or across centers.
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Production environment oversight.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.