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Head of Quality Assurance - Menlo Park, United States - Oruka Tx
Description
About Us:
Oruka Therapeutics is a newly launched company whose mission is to restore skin health.
We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts.
We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people.
As we build our core team, we're seeking a Program Management leader who is not just looking for a job, but an opportunity to be part of something bigger.
Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Position Overview:
As the head Quality Assurance, you will be responsible for establishing and leading the Quality function at Oruka Therapeutics.
You will develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development activities.
You will oversee the development of a phase appropriate quality system architecture that can flex across different clinical stage products and risk profiles.
You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment.
You are a hands-on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers.
You have a strong background in GxP quality, with an emphasis on GMP and external manufacturing CDMO interaction and partnership.
Key Responsibilities:
Strategic Leadership:
Establish, enhance, and manage the quality and compliance activities across a network of outside contractors accountable for the development, ongoing manufacturing, and eventual commercialization of products.
Advise senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues.Develop and mature a quality governance system that tracks the business with internal and external KPIs and holds departments and vendors accountable for deliverables.
Drive execution of strategic and operating plans while maintaining operational effectiveness.Quality Systems Implementation:
Oversee the selection and implementation of a QMS including establishment of document control procedures in support of critical drug development activities.
Ensure compliant and efficient support of the QMS including processes and supporting documentation (SOPs), Training, and a Quality Risk Management program.
Establish and drive metrics for the overarching QMS including, Issue/Deviation, CAPA and Change Control programs.Quality Oversight:
Lead a cross-functional group and establish an industry standard quality function that supports preclinical to commercial phase programs and products ensuring GxP compliance.
Lead and support GMP investigations associated with critical and major deviations. Oversee and manage all quality and compliance issues, ensuring appropriate CAPA plans are defined and implemented. Develop a best-in-class program for vendor qualification including supplier management and auditing, as well as internal audit management.Plan and conduct/coordinate GxP (GCP, GLP, GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines.
Develop a roadmap for inspection and execute key activities needed to achieve business goals.Qualifications:
Bachelors or Advanced degree in a scientific field with a minimum of 15 years of experience in quality assurance roles in a biotechnology or pharmaceutical setting.
Comprehensive knowledge of drug development from research through development including in depth knowledge of GxP regulations.
Strong analytical and problem-solving skills, with the ability to design creative solutions to complex challenges.
Experience in leading and managing regulatory inspections.
Proven experience in successfully standing up new GxP vendors, including interfacing with new CDMOs and negotiating solid quality agreements.
Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff.
Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.
Able to travel domestically and internationally.
What We Offer:
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Flexible work arrangements opportunity for hybrid work between home and our Boston Area office.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Are you currently fully eligible to work in the United States of America? *Do you now or will you, at a future date, require visa sponsorship to work in the United States? *If not located in the San Francisco Bay Area or Boston Area, are you open to relocation? *#J-18808-Ljbffr
