Back to Open Positions

Senior Manager, Quality Assurance

Location: Philadelphia, PA

Job Description

JOB TITLE: Senior Manager, Quality Assurance

REPORTS TO: Associate Director, Quality Assurance

POSITION SUMMARY

Tavanta Therapeutics (Tavanta) 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 Associate Director, Quality Assurance, the incumbent will be responsible for working to execute, manage and enhance the Quality Management System (QMS) at Tavanta.

The corporate culture at Tavanta is grounded in the core values of accountability, teamwork, and support. It is the responsibility of every person to emulate and abide by these values as the company continues to grow.

  • We are all accountable for efficient and effective development of products that help patients with unmet medical needs through focus on innovative strategies and operational excellence
  • We value teamwork and work in high-performing teams whose success is based on trust, transparency and integrity
  • We challenge each other. We motivate each other. We support each other.

Essential Duties and Responsibilities

  • The Senior Manager, Quality Assurance will work directly with senior leadership to execute, manage, and enhance Tavanta’s QMS across the organization.
  • This is a highly-visible role within the organization and the incumbent must be solution-oriented in their approach to handling Quality and compliance challenges.
  • This is a broadly-focused quality role, primarily requiring expertise in Clinical study oversight. The position may need to become involved in Chemistry, Manufacturing & Controls (CMC) areas on a supporting basis.

Responsibilities will include:

  • Providing quality oversight for clinical studies (Phase I, II, III) from start-up through execution
  • Partnering with clinical functions to educate, train and implement applicable Quality and Compliance structure and processes regarding clinical trials
  • Providing Quality review / approval of clinical trial documents (protocols, investigator brochure, protocol deviations, serious breach incidents)
  • Partnering with Clinical, CMC and Regulatory Affairs to solve problems and creatively meet aggressive timelines related to clinical supplies
  • Developing and writing company policies, standard operating procedures and work instructions

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 5-7 years direct experience with Quality responsibility in the pharmaceutical / biotechnology / specialty pharmaceutical field. Some smaller company experiences preferred.

Additionally, the candidate should have:

  • A thorough understanding and working, practical knowledge of both FDA and ICH Quality requirements for pharmaceutical drug development, including a strong, demonstrated understanding of GCPs and GMPs, as well managing and improving a Quality Management System
  • Extensive, demonstrated experience collaborating and partnering with global contract development manufacturing and clinical research organizations
  • Demonstrated the 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
  • Cultural awareness working with team, vendors, and stakeholders across countries

Qualifications

Skills and Behaviors

The Senior Manager, 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, able to roll-up their sleeves every day and execute on the deliverables and requirements of the role and the company

Work Environment

This position is currently home-based but may require travel of up to 25%, including attending the corporate office in the King of Prussia, PA area on an as-needed basis.

During the current Covid-19 pandemic, all US-based Tavanta employees are currently working remotely. In the future, office hours at pre-determined times may occur.

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift

COVID-19 considerations:
During the current Covid-19 pandemic, all US-based Tavanta employees are currently working remotely. In the future, office hours at pre-determined times may occur.

Application Question(s):

  • What is your experience managing quality at external partners (i.e. CDMO, CRO)?

Education:

  • Bachelor’s (Required)

Experience:

  • Quality assurance: 5 years (Required)
  • GMP / GCP: 5 years (Required)

Work Location:

  • Fully Remote
  • Apply Now

    Fields marked with (*) are required.
  • Accepted file types: pdf, doc, docx, Max. file size: 50 MB.