Posted to MedZilla on 1/19/2019


Takeda Pharmaceuticals

US-IL, Quality Management Support SR0031029-MZ


 
 

Primary Role as Quality Management Support Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Takeda 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. Center Quality Assurance Oversight: (65%) Provide on-site support of Center Quality needs Serve as a Subject Matter Expert (SME) by maintaining a high level expertise in current regulatory requirements. Provide training and coaching to local and other employees as relevant on quality related matters. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with Plasma Center Management and other internal groups to perform the assessment and influence necessary actions. Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans. Works in collaboration with center manager and management team to prepare for internal auditors and external inspectors. Provide new center inspection support and review inspection summaries. Assists center management teams to ensure timely closure of audit observations. Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Regulatory Compliance: (15%) Stays current with all federal, state, local and company-specific rules, regulations, and practices. Ensures Plasma Center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Assesses and ensures compliance for new center licensure. Ensures that SOP s are current and that staff perform routine tasks according to SOP through direct observation. Continuous Improvement: (20%) Identifies potential SOP revisions as needed to support continuous improvement for Quality Operations Training Collaborates with cross functional work teams to identify quality improvement opportunities as they related to Plasma Center Development. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions. Key Skills and Competencies Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Leadership Behaviors Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others 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. Reports to Associate Quality Assurance Director (Internal) Consults and coordinates directly with the Center Management, Quality Management and Regional Management on quality concerns within a 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. Other Job Components Complexity and Problem Solving Responsible for providing guidance and expertise to Center and Quality Management teams Refers to Associate Quality Assurance Director for guidance on complex, high-impact or urgent decisions (internal) Responsible to collaborate with cross-functional Quality Operations Team members on decisions impacting Center Development Internal and External Contacts Reports to Associate Quality Assurance Director (Internal) Consults and coordinates directly with the Center Management, Quality Management and Regional Management on quality concerns within a 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.

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

 
 


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