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Senior Manager, Clinical Compound Support Quality Assurance

Takeda Pharmaceuticals

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Location: Chicago, IL Posted Date: 5/6/2013 Position Type: Full time Job Code: 1300232 Required Education: Bachelors Degree

Description

OBJECTIVES:

* Manage TGRD Clinical Compound Support Program Managers.  Ensure that investigator, vendor, facility and system audits are conducted, and communicate any critical compliance risks noted from these activities to Quality Assurance senior management.  Ensure that corrective actions are implemented.

* Serve as a strategic GCP quality resource to TGRD for its drug development activities.

* Collaborate with PDD Global Compound Support and with all TGRD functional areas to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.

* Maximize effectiveness and efficiency in use of internal and external resources in conducting clinical compound support quality assurance activities.
ACCOUNTABILITIES:

* Provide direction to the Clinical Compound Support Quality Assurance Program Managers to ensure the development and implementation of strategies, processes, procedures and quality standards required to maintain compliance with applicable regulations.

* Analyze audit program results, quality issues, and investigations in order to optimize regional operations and overall regional state of compliance. Ensure that activities are conducted and reports written according to applicable SOPs and regulations.

* Represent Clinical Compound Support during regulatory inspections.  Assure that responses are timely and appropriate to maintain TGRD's good standing with regulatory agencies.

* Collaborate with PDD Global Compound Compliance and PDD Quality Systems to identify and mitigate GCP/GLP/ and bioanalytical quality and compliance issues with potential impact across multiple compounds, sites, or functional groups within or outside of TGRD including TGRD EU, TGRD Asia, and JDC (Japan Development Center).

* Determine acceptability of vendors for potential use by TGRD US .

* This position supports the ongoing development and operational success of the Clinical Compound Support Quality Assurance (CCSQA) function. This includes talent development and succession planning, resourcing and budgeting, and alignment of CCSQA initiatives, goals and activities with PDD, TGRD and TPC goals.

* Provide direct supervision of Clinical Compound Support Program Managers, with responsibilities for  staff selection, work assignment, SOP training, completion of goals, growth plan development, and completion of performance reviews.  Provides mentoring and training to staff.

* Coach and educate external sites and cross functional TGRD staff in FDA regulatory readiness activities and responses in support of successful marketing submissions.

* Communicate expectations for Clinical Compound Support Quality Assurance with respect to interactions with and support of Clinical Research teams.

* Monitor compliance issues identified across clinical programs. Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution across TGRD.

* Review and approve observations, reports, and ratings of audits conducted and written by direct reports in Clinical Compound Support  group.

* Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures.  Provide appropriate risk analysis for key stakeholders to make critical decisions.

* Monitor the qualifications of direct reports and institute remediation training to comply with standards defined by Clinical Compound Support management.

* Provide quality assurance leadership to drug development teams.  Act as a quality resource with expertise in regulations relating to GCP, ICH guidelines, and Clinical Operations SOPS.

Requirements

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

* B.S. in Science, Nursing, or related scientific field.

* 10 years of applicable pharmaceutical drug development/clinical experience with at least 6 years of GCP-related Quality Assurance experience.

* 3+ years of direct personnel management experience.In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation

* Auditing Knowledge:  Demonstrates intermediate to advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

* Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.

* Product Knowledge: Understands the medical/therapeutic impact of products.

* Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects.  Understands medical terminology and is familiar with standards of care and disease states.

* Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents.  Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.

* Negotiation Skills:  Demonstrates proficiency in negotiation and conflict resolution.

* Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.

* Organizational skills: Must be able to prioritize work effectively to meet timelines.

* Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.

* Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
LICENSES/CERTIFICATIONS:

* ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional #8211; GCP certification preferred.
PHYSICAL DEMANDS:

* Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

* Carrying, handling and reaching for objects.

* Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

* Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

* Requires approximately 25 % travel.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
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