Responsible for overseeing Quality Assurance operations for BioLife Plasma Services in North America within assigned District to include multiple plasma collection centers.
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 Quality management.
Quality Operations Management (50%)
Ensures Quality System requirements are deployed and met for:
BioLife NA Plasma Collection Centers
BioLife HQ Quality Systems
Quality Training and Support Functions
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 QMRs 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.
Maintains a strong understanding of operations and provides input and recommendation pertaining to the implementation of new changes impacting quality.
Employee Training & Development (30%)
Manages performance expectations and accountability of center/group quality managers in planning and goal setting, increasing quality efficiencies, quality metrics, and staff development.
Culture champion - drives a culture of positivity and retention, through completion of in-person field based engagement at assigned locations, and makes recommendations based on feedback received (aligned with HR).
Supervises and coordinate training of Quality Management Reps 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 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 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).
Computer skills in word processing, spreadsheets, and databases.Â
Demonstrated understanding of quality assurance in an FDA-regulated environment.
Demonstrated understanding of plasma center operations.Â
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Disciplined action and execution, ability to drive operational excellence, promote teamwork, and communicate effectively.
Ability to build strong relationships with strong technology application and analytical skills.
Working basic knowledge of applicable state/local regulatory requirements and how those requirements impact the facilities that are being supported.
Strong capability to engage, communicate, and work effectively with individuals of varying job levels, geographic locations and dispositions.
Aptitude in using Risk Management for decision making and recommending process.
Decision-making and Autonomy
Ability to manage strategically required
Authority to make hiring/separation decision regularly (involuntary must collaborate with HR)
Office based, mainly web-ex, phone and email interaction.Â
Incumbent seeks advice from Regulatory Affairs, Medical Affairs, and other key stakeholders, in complex and/or high risk quality related matters. (Internal)
Job advises employees and manager regularly on various topics, including quality, performance, personal development, SOP interpretation, and regulatory inspection topics. (Internal)
Position requires interacting with and/or discussing operational questions/issues surrounding center equipment with said manufacturers. (External)
Ability to think innovatively required
Ability to manage in a fast-paced, challenging environment while remaining focused on obtaining objectives is a must.
Ability to make decisions regarding quality at the Center, District, and Regional levels.
Ability to make decisions for the Quality Training and Support group.
Ability to refer high level problems to Regional Quality Manager or Head of Quality Field Operations.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: Bachelorâs degree
Good communication and negotiation skills.
Thorough knowledge of FDA and EMA GMP requirements.
Experience in managing regulatory inspections.
3-5 years quality related in Blood or Plasma collection industry.
3-5 years managing other quality professionals.
Previous auditing experience is highly desirable
ADDITIONAL INFORMATION (
FLSA Classification â Exempt
Field based role in California
Ability to travel 50% or more domestically to assess center quality, assess QMRâs performance, support inspections, and/or travel with operations counterpart to assess center culture and growth opportunities.
California - Virtual
Internal Number: R0027929
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.
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