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Associate Director, Quality Assurance

Location: Philadelphia, PA

Job Description

JOB TITLE

Associate Director, Quality Assurance

 

REPORTS TO

Kevin P. Malobisky, Ph.D., M.S., RAC

Chief Regulatory and Strategic Operations Officer

 

POSITION SUMMARY

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 Regulatory and Strategic Operations Officer, the incumbent will be responsible for working to develop and implement a Quality Management System (QMS) and have oversight of QXP Quality at Tavanta.

 

Essential Duties and Responsibilities

  • The Associate Director, Quality Assurance will work directly with senior leadership to build, develop, and implement a QMS across the organization
  • This is a highly visible role within the organization and the incumbent must be solution-oriented in their approach to Quality and compliance challenges
  • Responsibilities will include:
  • Developing and writing company policies, standard operating procedures, and work instructions
  • Partnering with research and development functions to educate, train, and implement applicable Quality and Compliance structure and process
  • Conducting vendor qualification and GxP audits both globally and domestically
  • Overseeing third party contract personnel to ensure audits are planned, scheduled, and conducted as required

Qualifications

Knowledge, Skills and Behaviors

Education and Experience

The candidate will have a Bachelor of Science in a scientific discipline; Master of Science preferred but not required.  In addition, the candidate should have a minimum of 7-10 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 required

 

Skills and Behaviors

The Associate 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

 

Work Environment

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

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