Director, Site Quality Head

Location
Rochester, New York
Posted
Nov 25, 2021
Ref
5580902002
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As the Rochester Site Quality Head, you will report to the VP, Head of Quality, Technical Operation, to provide the quality oversight on the facility startup, qualification and validation activities, and the daily quality operations at the site.

What you'll do

  • Provide quality oversight for the facility startup, including the qualification and validation activities
  • Build (GMP) quality systems and the compliance infrastructure. This includes the SOP system, training programs, and performing audits
  • Approve materials and product specifications
  • Make product disposition decision
  • Prepare product and process quality reports by collecting and analyzing information and trends
  • Lead inspections by FDA, other regulatory agencies, and partners
  • Represent Quality function to achieve site goals and maintain compliance to corporate quality standards and the regulatory agencies around the world
  • Active & collaborative member of the site leadership team, operational leadership team, and support the management team where required
  • Establish the strategic plans and goals for the site Quality organization by making final quality decisions on administrative and operational matters at the site

What we're looking for

  • Familiar with the US, EMA, and ICH regulations and guidance documents
  • Demonstrate ability to engage team members across diverse teams
  • Promote curiosity, scientific rigor, and excellent problem-solving skills
  • Experience implementing Quality/Compliance systems
  • Collaboration skills
  • Experience with Project Management and Analytics software
  • BA or BS in life science degree
  • 10+ years' experience in the pharmaceutical or biotechnology industry in a quality or compliance function

What will separate you from the crowd

  • Cell and Gene Therapy product experience
  • Successful facility startup and regulatory inspection experience

What you should know

  • Working safely in person on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.