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Plasma Center Quality Leadership Opportunities

District Quality Manager- West Region

California
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Job ID R0027929

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Job Description

OBJECTIVES/PURPOSE

  • 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.

ACCOUNTABILITIES

  • 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.  

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. 
  • Demonstrated understanding of quality assurance in an FDA-regulated environment.
  • Demonstrated understanding of plasma center operations. 

Leadership

  • Integrity
  • Fairness
  • Honesty
  • Perseverance
  • 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)

Interaction

  • Office based, mainly web-ex, phone and email interaction. 
  • 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)

Innovation

  • Ability to think innovatively required

Complexity

  • 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: Bachelor’s degree

Desired:

  • 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 – Exempt
  • Field based role in California
  • Ability to travel 50% or more domestically to assess center quality, assess QMR’s performance, support inspections, and/or travel with operations counterpart to assess center culture and growth opportunities.

Locations

California - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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2. Your First Review

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3. Your First Interview

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4. Job Offer

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5. Pre-Employment

After electronically accepting your offer, you’ll receive communications electronically which will guide you through the pre-employment process.

6. Onboarding

Once you complete the pre-employment process, we’ll arrange a date for you to join the team, with an onboarding session taking place in your first few weeks at the company.

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