Sr Quality Specialist, Clinical Quality

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Job Description

OBJECTIVES/PURPOSE

• Sr. Quality Specialist, Clinical Quality responsible for managing clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.
• Works in collaboration with local clinical operation team ensuring adherence to Good Clinical Practice Guidance.

ACCOUNTABILITIES

• Drives the development and implementation of CQA procedures and local QMS (including GCP compliant process development) for managing local Clinical trial quality assurance in accordance with internal procedures.
• Responsible as cross functional reviewer (where applicable) and quality authorizer as per internal procedures.
• Establishing and maintaining local risk register. Engage the key LOC stakeholders to proactively identify GxP (primary focus GCP) quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC.
• Lead supplier and individual clinical study audit(s) (internal and external including clinical site(s)) in accordance with internal procedures
• Provide independent quality and compliance oversight for GCP suppliers, including but not limited to coordinating the development and execution of Quality Agreements, attending Governance meetings etc.
• Initiate Quality Incident Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure.
  • Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks such as any Critical findings noted during supplier audit to be notified to Local Management on an immediate basis (as required by Takeda Audit procedure)
  • Support core governance for deviation/incident management for critical or major deviations pertinent to the clinical trials being assigned. Review and approve them as deemed necessary.
• Maintenance of LOC QMS system and ensuring its KPI’s are met. This includes handling of applicable QMS elements (including but not limited to) Change control, deviations, CAPA, complaints, Risk mitigation, gap assessments etc for GxP activities. This includes QA support in PV & RA gap assessment quality review
• Responsible to ensure local Quality Council is conducted on a regular basis. Generate metrics and develop reports on GCP supplier quality performance
• Guiding Clinical Operations for adequate root cause identification, conducting gap analysis and implementation of corrective action plan (CAPA).
• Provide GCP guidance to day-to-day questions arising from Clinical trials deliverables, as well as participate in review and approval of critical Clinical Study documents (e.g., Protocols), as appropriate
• Provide guidance to internal Takeda stakeholders such as clinical operations team, Clinical supply, regulatory affairs and external supplier or Business Partner (as applicable) for day-to-day questions arising from Clinical trials deliverables pertaining to GCP compliance requirements, supplier governance and supplier quality oversight procedure & initiatives.  as well as participate in review and approval of critical Clinical Study documents (e.g., Protocols), as appropriate
• Providing support during self-inspection, Takeda internal audits, supplier audit, any Regulatory inspection for LOC
• Manage relationship, relevant communication and inspection with local regulatory authority on GCP. Ensure regulatory commitments are duly completed on time
• Performing risk assessment of local GPvP vendors and schedule the audit accordingly.
• Execution of Local GPvP vendor audit plan. Maintaining oversight if audit conduct shall be outsourced to consultant auditor.
• Maintain training management for local Quality procedures in Takeda LMS and assignment of it to identified target GxP audience (under the role of system training administrator)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Good knowledge and understanding of the pharmaceutical industry, local clinical trial regulations and understanding of ICH E6, ICH E3, ICH E8, ICH E9
• Excellent knowledge of cGxPs, quality standards and industry best practices

Leadership

• Ability to collaborate and partner well with cross-function stakeholders locally
• Organization agility (knowledgeable about how an organization works) and ability to lead change, deliver strong results and build the confidence of stakeholders
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
• Execute goals and objectives in a driven and a high-performance culture with ability to achieve results

Decision-making and Autonomy

• Anticipate potential problems and risks related to quality systems/regulatory expectation, assess potential impact, implement compliant solutions to issues.

Interaction

Internal

• Key interactions with local key stakeholder groups to stay connected with business and respond to business needs.

External

• Key interactions with CROs partners (as identified) to maintain good quality support.

Innovation

• Understanding of local industry, scientific and regulatory trends, and its market conditions and requirements.

Complexity

• Multiple external CROs, regulatory framework, and a wide diversity of products.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Life Sciences Graduate/Postgraduate with 7-10 years of years’ experience in clinical trial industry as Clinical Quality Auditor
• Ability to work independently and identify compliance risks and escalate when necessary
• Strong sense of urgency
• Demonstrated interpersonal skills including strong negotiation skills
• Excellent teamwork and coordination skills
• Excellent verbal and writing skills and fluent in English and as applicable, local language is desired

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Strong communication and stakeholder management skills
• Ability to influence and work effectively with local cross-functional team
• Agility and ability to manage complexity & balance priorities
• Risk identification, evaluation, and management.

Leadership Behaviors

• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

ADDITIONAL INFORMATION

Domestic travels up to 30%

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