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Head of Quality

Location: Philadelphia, PA

Job Description

JOB TITLE

Dir. QA – Head of Quality

REPORTS TO

CEO (later VP Regulatory, once position is filled)

TAVANTA THERAPEUTICS, INC.

Tavanta Therapeutics is a clinical stage specialty pharmaceutical company developing a diverse pipeline of drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases. As we continue to grow and expand, there exists an immediate opportunity for a Quality Assurance professional to join our Team. Reporting to the Chief Executive Officer, the incumbent will champion a QA culture and a top-notch Quality Management System (QMS) and have oversight of Quality at Tavanta.

POSITION SUMMARY

The head of QA will lead a state-of-the-art QA function and will embed quality thinking in all organizational activities. The head of QA will lead a team of QA professionals that will train and educate Tavanta staff about quality regulations and standards. The head of QA will maintain an up-to-date, innovative quality management system that will provide maximum support to all Tavanta program activities. The head of QA and the QA team will ensure ongoing and full compliance with regulatory standards and will conduct necessary enforcement and oversight of internal and outsourced program activities.

 

Objectives of the role

 

  • Nurture a quality culture that lives by the highest GxP standards
  • Maintain an up-to-date quality management system and ensure company-wide integration of QA objectives
  • Ensure GxP compliance with FDA, ICH and related quality system regulations & standards
  • Ensure QA oversight of internal functions and all external GxP providers for Tavanta

Responsibilities & Deliverables

Culture

  • Work in close collaboration with peers to nurture a quality culture that proactively incorporates quality standards in program activities
  • Lead planning activities to drive quality performance and quality across the organization
  • Lead GxP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies
  • Provide guidance, interpretation, and information on GCP and GLP regulations, standards, and quality systems
  • Setup and chair a Quality Board to promote quality oversight and continuous improvement

 

QMS

  • Develop and implement standards, policies, and procedures to benchmark GxP regulatory compliance
  • Maintain a QMS quality system including elements such as deviations, CAPAs, change controls, training programs, and procedural documents
  • Track external regulations and standards and update procedures to conform to latest versions (cf. ISO, ICH, FDA standards)
  • Lead continuous improvement initiatives and projects to improve processes, and upgrade the quality documentation system to meet expanding quality activities
  • Direct, coordinate, and track QA team’s efforts, ensuring milestones are met within defined budgets and schedules.

 

Compliance

  • Formulate GxP compliance strategy and provide advice for all programs within Tavanta
  • Assess GxP compliance risk areas and develop and implement risk mitigation measures
  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers
  • Partner with all internal departments and external providers regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement
  • Manage QA reviews of project‐related essential clinical study documents
  • Prepare internal QA reports and provide input for external partner reports and/or regulatory filings
  • Report and escalate compliance issues to management, including requests for directed audits

 

Oversight

  • Develop and prioritize an audit strategy for all programs
  • Oversee supply management processes, including supplier approval and monitoring
  • Plan and lead GxP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories, CROs, CDMOs to determine compliance status and identify compliance risks
  • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented

Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any

Qualifications

Knowledge, Skills and Behaviors

Education and Experience

A Bachelor of Science in a scientific discipline; Master of Science is preferred but not required.  In addition, the candidate should have a minimum of 10-12 years direct experience with Quality responsibilities working in a small biotechnology and/or specialty pharmaceutical company.

  • Thorough understanding and working knowledge of both FDA and ICH Quality requirements for pharmaceutical drug development including a strong, demonstrated understanding of GCPs, GMPs, and GPVPs, as well as building and implementing a Quality Management System
  • Must have extensive, demonstrated experience collaborating and partnering with global contract development manufacturing and clinical research organizations
  • Demonstrated ability to think creatively, work within a team environment, and collaborate effectively in a time-efficient manner
  • Strong oral, written, presentation, and negotiation skills are required
  • Cultural awareness working with team, vendors, and stakeholders across countries

 

Skills and Behaviors

The Director, Quality Assurance must be an enabler and educator to internal and external teams and stakeholders.

 

Required skills and behaviors include:

  • Team oriented and goal-driven while being self-aware of strengths and weaknesses
  • Highly organized and able to work on his/her own with limited oversight
  • Collaborative, creative, and open-minded, and eager to help others
  • Persistent and optimistic about overcoming obstacles and uncertainty
  • Flexible and willing to try/learn new things and approaches
  • Willing and able to roll up the sleeves every day

 

Work Environment

This position will be in the  greater Philadelphia area, PA headquarters location with the possibility of up to 25% domestic and global travel.

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