| By clicking the âApplyâ button, I understand that my employment application process with Takeda will commence and that I agree with Takedaâs Privacy Notice, Privacy Policy and Terms of Use. Job DescriptionOBJECTIVES/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. 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
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.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)
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: Bachelorâs 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 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.
LocationsCalifornia - Virtual Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time |
