Sr. Director, Quality GCP/GLP
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You'll Do
You will be responsible for all Quality Assurance GCP activities. This role will ensure the quality and compliance of clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices), as well as support the non-clinical team on ensuring GLP studies are conducted in a compliant manner. You will support all GCP and GLP regulatory inspections internally and at vendor or trial sites and ensure all pharmacovigilance requirements for global needs are conducted according to appropriate ICH GCP standards.
You will schedule, perform and manage routine and non-routine quality assurance audits including: clinical investigator sites, animal testing sites, vendors, process, system, study project and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines. You will provide GCP and GLP QA oversight and support to EQRx internal staff. You will assist Clinical Ops in the development of Clinical SOPs and other quality documents. You will develop and implement detailed audit plans and yearly GCP /GLP audit schedules. This role will ensure the timely and effective follow up of all identified or assigned quality issues and assist in preparing investigational sites for regulatory inspections. You will conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents. You will also conduct QA review of GLP reports. You will oversee delivery of yearly GCP training for internal staff. You will also assist with GCP training of study site personnel as required.
The Impact You Will Have
This is not your standard Sr. Director, QA role. We are doing things different here than how it is normally done, and this role is no exception. This role is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
Who You Are
- You have a bachelor’s degree in a scientific discipline.
- You have a minimum of 8 years’ experience in the Pharmaceutical industry with a minimum of 5 years in GCP QA.
- You have a solid understanding of GCP, GLP and ICH clinical requirements.
- You have experience with both domestic and international clinical studies.
- You can participate and work effectively on multiple cross-functional teams.
- You play well in the sandbox. You understand relationships are key and have strong interpersonal skills.
- You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
- You can thrive in a smaller company environment and love the pace of a true startup.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Are you bold enough?
Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.
We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for?
Are you ready to think differently and embrace the journey?
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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50 Hampshire StreetTwo-hour street parking is available. There are also several parking garages in the surrounding area.
Cambridge, MA 02139