About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
Responsible for managing the quality of two to four plasma collection facilities, to include back-up support for Regional Quality Leads, training, audits, special projects and general administrative responsibilities associated with quality management. This would also include effectively managing 1-3 center QMR’s on
their daily responsibilities while reporting all information to the defined Regional Quality Lead.
Quality Management (40%)
Oversees the quality of 2-4 plasma collection centers. This includes maintaining compliance with all federal, state, local and company regulations related to quality of product.
Works in collaboration with Facility 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
Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
Tracks responses to and evaluates effectiveness of corrective actions for errors.
Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations in operating procedures and policies through established mechanisms. Re- ports errors, deficiencies, discrepancies and observations to center management and Regional Quality Management Representative. May stop operations or shipments when donor or product safety is or may be compromised.
People and Culture Management (30%)
Provide quality support for other centers within the region.
Responsible for training new QMRs and other quality personnel.
Coordinates management review meetings and participates in center staff meetings.
Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases.
Take the initiative to work with Regional team members and provide support as needed across region- al divisions. Responsible for providing feedback and developing employees in the quality department.
Administrative and Strategic Analysis (20%)
Analyzes trends and reviews quality data to determine opportunities for continuous improvement. Manages corrective action procedures to ensure timely and effective resolutions.
Identifies potential SOP revisions as needed to support continuous improvement.
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 re- lease, quality assurance, and employee training program.
Other Duties and Projects as Assigned (10%)
Serve as BioLife Guest Auditor.
Work to obtain Lean Greenbelt Certification, including completion of applicable classroom training and projects.
Lead quality-related projects within the center and region.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved pro- cedures (including but not limited to 5S, Value Stream Mapping and Kaizen)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Computer skills in word processing, spreadsheets and databases highly desirable.
Effective organizational, technical and problem-solving skills.
Demonstrated understanding of quality assurance in an FDA-regulated environment.
Demonstrated understanding of plasma center operations.
Effective organizational, technical and problem-solving skills.
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Resolves moderate to moderately complex quality concerns. Has hiring and separation discretion for applicable quality roles.
Works with Regional Quality Lead and HR on complex quality and/or employee relations issues.
Hiring and Separation decision making authority (involuntary separations must consult HR)
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.
Effective coaching and counseling skills.
Collaborates with Regional Quality Lead, Human Resources, Finance, Operations Management, OE and various other departments regularly
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).
Must be able to travel 25-30% of the time. Regular travel required between assigned BioLife locations, with an expectation that Group Manager is working in one of the assigned locations and visits each center at least once per week.
Potential exposure to blood borne pathogens.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: Minimum two to three years of relevant work experience, or an equivalent combination of education and experience. Proven success performing as Quality Management Representative with demonstrated experience meeting and exceeding plasma center quality goals.
Desired: Bachelor’s Degree.
FLSA Classification (US) - Exempt
Other duties and responsibilities as assigned.
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.