Group Quality Manager
Company: Biolife Plasma Services
Location: Attleboro
Posted on: June 14, 2022
Job Description:
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in my employment application is true to the best of my
knowledge.Job DescriptionAbout BioLife Plasma ServicesEvery 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.OBJECTIVES/PURPOSEResponsible 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 ontheir daily
responsibilities while reporting all information to the defined
Regional Quality Lead.ACCOUNTABILITIES
- 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 ASPECTSTechnical/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.Leadership
- Integrity
- Fairness
- Honesty
- Perseverance
- Putting the patient at the center
- Building trust with society
- Reinforcing our reputation
- Developing the businessDecision-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)Interaction
- 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
regularlyInnovation
- 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
- 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.ADDITIONAL INFORMATION
- FLSA Classification (US) - Exempt
- Other duties and responsibilities as assigned.EEO
StatementTakeda 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.LocationsUSA - MA - AttleboroWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Biolife Plasma Services, Attleboro , Group Quality Manager, Accounting, Auditing , Attleboro, Massachusetts
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