Back to jobs
Director, GxP Quality Assurance and Compliance
New York; Cambridge, MA
We are looking to hire a Director, GxP Quality Assurance and Compliance to join us in our mission to discover and develop drugs that improve human health through the use of breakthrough computational methods. We are seeking outstanding individuals to join our drug discovery group and contribute to our rapidly expanding portfolio of drug discovery programs and collaborations.
Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers, as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Several programs we have worked on have achieved developmental candidate status, and have progressed into clinical development after IND approval. You can view our entire pipeline of wholly-owned programs and collaborations here.
Who will love this job:
- A strategic subject matter expert who’s ready to partner with cross-functional teams as an experienced Quality technical resource
- A solutions-oriented and collaborative coach to internal partners
- An excellent verbal and written communicator with robust project management skills
- 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
What you will do:
- Overall GxP Responsibilities:
- Design, develop and implement overall GxP Quality Assurance strategy and vision for Schrödinger’s Therapeutics Group
- Develop, implement, and manage the continuous improvement of robust quality management systems, including, e.g., vendor management, deviation management, change control, CAPAs, product label review, risk management, and eQMS (MasterControl)
- Ensure compliance, in collaboration with relevant SMEs and senior leaders, with all applicable GxP regulations, including GMP, GCP, and GLP
- Establish key quality system metrics and process indicators to proactively identify and address quality systems or product issues
- Oversee the development and implementation of all relevant training programs to ensure staff are knowledgeable about GxP requirements and quality standards
- Provide leadership and guidance to teams on inspection readiness, including hosting and participating in regulatory inspections (GMP, BIMO, etc.)
- Account for appropriate oversight of all vendors, including CDMOs and CROs, to ensure regulatory compliance
- GMP Responsibilities:
- Serve as spokesperson and technical subject matter quality expert for all matters governed by GMP-related regulations/guidelines and industry best practices (e.g., FDA, EMA, PMDA, etc.)
- Perform and manage day-to-day GMP QA activities
- Author, review, and approve all relevant GMP quality documents
What you should have:
- Bachelor's degree in life sciences (Master’s degree in life sciences preferred)
- Twelve to fifteen years of Quality Assurance experience in the pharmaceutical or biotech industry, with at least five years in a leadership role
- Technical quality experience preferred
- Experience in manufacturing operations preferred
- Expert level knowledge of GMP regulations and FDA requirements, Guidance documents, and industry best practices, with a focus on Analytical/QC testing
- Good working knowledge of global GxP standards, including USP/Ph., FDA/EMA, and ICH
- History of success with the management of inspections performed by the FDA and other regulatory bodies
- Excellent written and oral communication skills
- Ability to travel domestically and internationally on occasion
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 regular catered meals in the office, 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.
Estimated base salary range: $185,000 - $235,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
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.
Apply for this job
*
indicates a required field