Posted to MedZilla on 11/13/2019


Takeda Pharmaceuticals

US-MO, Plasma Center Quality Manager SR0040135-MZ


 
 

BioLife s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off (new hires are eligible for 25 days per year), on the job training, tuition reimbursement (up to $10,000/year), advancement potential AND an environment full of fast-paced fun all while working to save lives.BioLife employees who work 20 or more hours per week are eligible for full benefits!

OBJECTIVES/PURPOSE

Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.

All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.

ACCOUNTABILITIES

  • Regulatory Compliance: (15%)
    • Stays current with federal, state, local and company-specific rules, regulations, and practices.
    • Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
    • Ensures that SOP s are current and that staff perform routine tasks according to SOP through direct observation.

  • Plasma Collection Center Quality Assurance Oversight: (80%)
    • Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
    • Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised.
    • Identifies potential SOP revisions as needed to support continuous improvement.
    • Works in collaboration with center 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.
    • Tracks responses to and evaluates effectiveness of corrective actions for errors.
    • 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 release, quality assurance, and employee training program.
    • Coordinates management review meetings and participates in center staff meetings.

  • Employee Recruitment and Retention: (5%)
    • Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases.
    • Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively.
    • Provides timely feedback on performance and initiates disciplinary action when necessary.
    • Participates in the evaluation and review of center staff.
    • Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Minimum of one-year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable.
  • Previous work experience within the plasma collection industry is strongly preferred.
  • Computer skills in word processing, excel, data analysis and databases highly desirable.
  • 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 business

Decision-making and Autonomy

  • Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
  • Refers to Group/Regional Lead for guidance on complex, high-impact or urgent decisions (internal)
  • Refers to management team for escalated donor/employee concerns (internal)

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.
  • Attend staff meetings and other team meetings as required.
  • Attention to detail and ability to work independently
  • Effective coaching and counseling skills.

Innovation

  • 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

  • Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
  • Production environment oversight.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential: High School Diploma or equivalent required.

Desired: Associates or Bachelor s degree highly desirable.

ADDITIONAL INFORMATION

  • FLSA Classification (US) - Exempt
  • Other duties and responsibilities as assigned.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people s lives including your own.

A subsidiary of Takeda, BioLife is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.