Director of Quality Assurance and Compliance

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Job description

We're seeking a Director of Quality Assurance and Compliance to join us in our mission to improve human health and quality of life through the development, distribution, and application of advanced computational methods!

As a member of our Drug Discovery group, you will oversee the Quality Management System (in accordance with government regulations and company policy) for a biotech specializing in clinical research. Your expertise in IND-enabling and early clinical development will make you an essential part of our team. You will report to the Head of Early Clinical Development.

Our drug discovery and early clinical development team includes a cross-functional group of experts advancing compounds into the clinic. Indications are therapeutically agonistic, but have a strong focus on oncology and inflammation/immunology. The group applies our proprietary physics-based drug design and optimization platform to the drug discovery process, which has successfully advanced ten programs into preclinical development, four programs into clinical development, and one to an FDA approval.

Who will love this job:

• An innovative and flexible collaborator who has the knowledge and experience to build out an end-to-end quality management system that is right-sized, robust, and reflective of regulatory requirements
• A goal-oriented team player who can bring excellent leadership skills to the oversight of cross-functional teams, including members of our toxicology, bioanalytical, CMC and clinical teams
• An advocate for patient centricity who can ensure the alignment of company activities with deliverables that are best from a patient's perspective

What you'll do:

• Lead QMS document preparation, review, finalization, and control
• Manage vendor qualifications and selection
• Lead audit and inspection workflow to ensure organizational readiness.
• Manage QMS training (assist with assigning curricula and ensuring that training is up to date)
• Conduct risk assessments, review service agreement terms, oversee corrective action plans, and provide input into budget approvals
• Coordinate communications between stakeholders
• Mentor colleagues and share knowledge / expertise across the organization

What you should have:

• At least eight years of experience in quality assurance
• An understanding of GCPs, GLPs, GMPs, and the pharmaceutical industry regulatory environment
• Robust experience in providing guidance and recommendations on implementing a GxP QMS.
• High proficiency with Google Suite and Microsoft Office
• Experience working with legal counsel
• Fantastic leadership skills, a collaborative spirit, and a willingness to take ownership for deliverables

Pay and perks:

Schrödinger understands it's people that make a company great. Because of this, we're prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain's New York Best Places to Work for the past three years running.

Sound exciting? Apply today and join us!

As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company's mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, "diversity" isn't just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn't mean better headlines or public images - it means increased adaptability and profitability.