Director, Quality Assurance

 

Turnstone Biologics Inc. is the leading virus-based immunoncology biotechnology company developing novel oncolytic vaccine therapeutics for cancer patients. Our first-in-class platform technology attacks tumours using a two-pronged approach: targed and robust tumour killing using an oncolytic virus, in combination with a cancer vaccine that generates long-lasting anti-tumour immune responses. Turnstone is building a world-class, high-performing team that embraces being a learning organization with a sense of urgency. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Canada and New York, USA. For more information, please visit www.turnstonebio.com.

 

How do you know if you’re the right fit? 

 

Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another Thursday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you. 

 

If you are interested in being a part of a growing Technical Operations team, then this role may be for you! As the Director, Quality Assurance, you will oversee the Quality function to ensure GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. 

 

The responsibilities includethe following:

  • Drive the development of the company’s Quality strategy and policies.
  • Oversee company-wide documentation practices, record keeping, training, auditing, raw material qualification and risk assessment, SOPs, batch records, study protocols, reports, investigations, analytical methods, and release specifications.
  • Lead all QA efforts and documentation for the compliant manufacturing of lead product candidates. 
  • Provide Quality Assurance and compliance oversight for contract manufacturers and research organizations to ensure products/deliverables meet all required quality standards and specifications.
  • Draft, review, and approve relevant sections of regulatory filings.
  • Build and scale the QA team to align with business objectives
  • Represent QA department at project and leadership team meetings.
  • Drive corporate and department objectives to completion through strong collaboration with a broad range of internal and external functions and levels of management
  • Cultivate a culture of quality and shared accountability throughout the organization to help ensure compliance with applicable regulations, guidelines, and corporate standards, policies and procedures.
  • Ensure that the company and its contactors (e.g., CMOs, clinical sites) are prepared for state, regional, or country authority inspections. Coordinate all authority inspections by ensuring sufficient resources are in-place to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.

 

What’s in it for you? 

 

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution.  With our company size and growth we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning?  We will have plenty of that for you!  

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportinites for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

 

The Details

 

This role is best suited for someone with the following:

  • BA/BS Degree
  • Minimum of 10 years of operational quality assurance and GxP compliance. Requires manufacturing experience in a pharma or biotech environment, preferably focused in viruses or vaccines, gene or cell therapy.
  • Prior experience implementing quality systems and advancing novel therapeutics from preclinical stages through IND to BLA is desired.
  • Effectively managed FDA inspections/audits, and conducted supplier/manufacturer audits.
  • Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
  • Ability to build/scale Quality functions.
  • Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.

 

 

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.