There is an incredible opportunity for innovation in the drug development process. We are reimagining what’s possible to build a more efficient and sustainable model.Christian Antoni, MD, PhD Chief Global Development Officer
Senior Manager/Associate Director of GCP 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.
Who We Are:
We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.
What You’ll Do:
The Sr. Manager/Associate Director of Good Clinical Practice (GCP) Quality Assurance will be responsible for helping to establish and sustain the EQRx Quality Management System for the area GCP including developing and monitoring performance metrics and key performance indicators to improve the performance and compliance across the organization to ensure continuous quality improvement.
You will be a key contributor to and support the systems of Corrective Actions/Preventive Actions (CAPAs) and Quality 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 the Pharmacovigilance and other Clinical Development functions, as necessary, to create a quality culture within EQRx and help reach a sustained state of inspection readiness and help maintains the master inspection tracker.
You will serve as the GCP Lead and be responsible for planning, execution, and effectiveness of the GCP audit program by either conducting service provider and internal audits or management of the outsourcing of such audits and by providing feedback into the master audit plan.
You will develop, review, and revise SOPs for GCP processes that accurately reflect best standard practices and regulations 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.
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, 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, key performance indicators and reporting and coordinate, develop, maintain and/or provide training as needed. You will also work to keep up with GCP 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 8-10 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 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 analyze 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 10-20% 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 are 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.
Are you ready to fight for enduring patient access?
- Problem Solving
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.
Stay in the Loop
Follow us on social.
We’re Remaking Medicine in a virtual-first environment. You can also find us at our Cambridge Hub.
EQRx Hub Location
50 Hampshire Street
Cambridge, MA 02139
Phone +1 (617) 315-2255