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, weâll 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 directing the Regional Quality Leads and overseeing Quality Assurance functions/operations for BioLife Plasma Services in North America. Responsibility include NA BioLife Collection Centers, Quality Training, and Quality Support Systems.
Ensures the deployment and effectiveness of the Quality System and approve audit responses and corrective action commitments.
Conducts Investigations, and reports non-conformance to procedures and regulatory requirements to the Head of BioLife Quality.
Quality Operations Management (50%)
Ensures Quality System requirements are deployed and met for:
BioLife NA Plasma Collection Centers
BioLife HQ Quality Systems
Ensure consistency of implementation of the quality systems across all locations.
Ensures compliance with all federal, state, local, and company-specific regulations related to quality of product, employee, and donor safety.
Stays current with federal, state, local, and company-specific rules, regulations, and practices.
Supervises Regional Quality Leads and District Quality Leads to ensure timely performance of the quality system requirements including CAPA, Change Control, and Management Review.
Ensures timely closure of internal and external audit observations.
Approve corrective action, ensure effectiveness and ensure timely audit responses FDA, EMA, China FDA, QPP, Customer, and PQAG.
Track, Trend, and Monitor Events relating to regulatory agency inspections.
Collect, analyze, and distribute quality data to the Leadership Team (LT), including Center Risk Rating, 483 Certification and center metrics.
Employee Training & Development (30%)
Supervises and coordinate training of Regional Quality Leads, District Quality Managers, and other Managers within the Quality group to ensure timely performance of quality system requirements.
Support regional and district operations, training, and support group operations by providing guidance and training on quality related topics.
Develops talent within the quality group and management teams to resolve center concerns independently.
Plan and execute multiple center visits to assigned regions/districts to interact with team members and to assess the culture as needed.
Other Applicable Projects as Assigned (20%)
Participate as needed in quality regulatory assessments internal and external to analyze risks.
Support Regional and District Operations by providing guidance and training on quality related topics.
Identifies/manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.Â Â
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Aptitude for working with statistical data (track and trend reporting and analysis).
Demonstrated understanding of quality assurance in an FDA-regulated environment.
Demonstrated understanding of plasma center operations.
Disciplined action and execution, ability to drive operational excellence, promote teamwork, and communicate effectively across the NA plasma center network.
Ability to build strong relationships with strong technology application and analytical skills.
Working knowledge of applicable state/local regulatory requirements and how those requirements impact the NA plasma centers.
Strong capability to engage, communicate, and work effectively with individuals of varying job levels, geo-graphic locations and dispositions.
Aptitude in using Risk Management for decision making and recommending process.
Putting the patient at the center
Building Trust with Society
Reinforcing our reputation
Developing the business
Effective coaching & counseling skills
Decision-making and Autonomy
Ability to make decisions regarding quality at the Center, District, Regional and Network levels.
Ability to make decisions for the Quality Training and Support groups.
Ability to refer high level problems to Head of BioLife Quality Ops.
Authority to make hiring/separation decisions.
Office based, video conferences, phone, email interaction, and onsite plasma center visits.
Seeks advice from Regulatory Affairs, Medical Affairs, and other key stakeholders, in complex and/or high risk quality related matters.
Advises employees and manager regularly on various topics, including quality, performance, personal development, SOP interpretation, and regulatory inspection topics.
Interacts with other departments in designing new processes and procedures.
Ability to work with internal and external groups in developing new computer systems.
Ability to work with other departments in making major changes to the operations of the NA plasma centers.
Ability to manage in a fast-paced, challenging environment while remaining focused on obtaining objectives is a must.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: Â Â Bachelorâs degree
Good communication and negotiation skills
Thorough knowledge of FDA and EMA GMP requirements.
Experience in managing regulatory inspections.
Minimum of 5 years quality related in Blood or Plasma collection industry.
Minimum of 5 years managing other quality professionals.
Previous auditing experience is highly desirable.
Internal Number: R0027632
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.