We believe it’s possible to have a profound impact on bending the cost curve in healthcare by building a pipeline of innovative medicines and bringing them to market at dramatically lower prices.Robert Forrester CXO
Senior Manager /Associate Director of GCP/GLP/GVP Quality Assurance
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
The Sr. Manager/Associate Director of GCP/GLP/GVP Quality Assurance, will be responsible for helping to establish and sustain the EQRx Quality Management System for the areas of GCP, GLP and GVP. You will be a key contributor to and support the systems of clinical Corrective Actions/Preventive Actions (CAPAs) and Clinical Issues, and other quality systems for ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). You will also be responsible to partner with clinical study teams and other Clinical Development functions, as necessary, to create a quality culture within EQRx and help reach a sustained state of inspection readiness. You will develop and implement QA compliance programs and conduct investigator site, service provider and internal audits.
You will develop, review, and revise SOPs for GCP/GLP/GVP QA processes and promote compliance within the company. This person will build, develop, and maintain good working relationships with internal and external partners and establish and enhance audit and inspection processes and procedures as needed. You will manage projects, including those with cross-functional teams. You will provide compliance advice as needed and help lead in inspections, in agreement with QA management. You will participate in company preparations for regulatory inspections and review and identify improvements that enhance the quality and clarity of audit reports.
In this role you will assist Quality management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement. You will help in resolving compliance issues at clinical sites, provide assessment of the impact of any deficiencies and participate in budget forecasting, planning, and tracking for QA. You will establish and maintain quality metrics and reporting and coordinate, develop, maintain and/or provide training as needed. You will also work to keep up with GCP/GLP/GPV requirements and developments.
The Impact You Will Have
This is not your standard quality assurance role. This position 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.
- You have a bachelor’s degree in a science (industry related discipline preferred) with a minimum of 10 years of relevant experience in a regulated environment.
- You have expertise in GCP regulations and guidance for FDA and International agencies including ICH guidelines, and in providing compliance advice.
- You have experience in planning, conducting, reporting clinical site and service provider audits (experience in GLP and GVP auditing a plus)
- You are SQA RQSP registered.
- You can train new and existing less experienced QA members.
- You have experience with Microsoft based applications and can learn new internal computer systems quickly.
- You have excellent knowledge of, and working experience with, relevant national / international regulations.
- You are details driven, with strong time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
- You can analyse complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
- You can identify quality issues/discrepancies, and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible, and constructive manner.
- You can travel an average of 10-30% annually.
- You can participate and work effectively on multiple cross-functional teams
- You understand relationships are key and have strong interpersonal skills.
- 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.
- Job Code: #LI-AL1
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 build a sustainable pipeline of excellent drugs at much lower prices?
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