ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing. The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. You can find us at shapetx.com and on LinkedIn and Twitter.
At ShapeTX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases.
Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Boston, Massachusetts.
ShapeTX is seeking a highly skilled, self-driven, and experienced Quality leader to join as our Head of Quality. Reporting to the COO, this highly impactful, visible, and collaborative Group Head will build and manage the Quality function to have a lasting impact on our company’s evolution, development of products, and future patient impact. Shape’s Head of Quality will oversee quality assurance and quality control, responsible for building the organization structure to establish and ensuring compliance with company quality policies, standard operating procedures (SOPs), and federal regulations. In this role, you will have the opportunity to work collaboratively across CMC, Clinical, Non-Clinical, Regulatory, and other Development-focused functions, to advance new programmable RNA therapies. This is a unique opportunity to oversee a critical area as Shape TX navigates the transition from Research-stage to Clinical-stage company.
What you’ll do
- Design, implement, and maintain (GxP) Quality programs, and the compliance infrastructure, including but not limited to the SOP system, training programs, and systems to manage internal and external audits.
- Build and lead right-sized, high functioning Quality teams.
- Ensure timely and accurate completion of Quality activities, including documentation and record keeping.
- Lead and manage inspections by regulatory agencies and commercial partners.
- Ensure all deviations, investigations, and corrective actions are properly documented and resolved in a timely manner.
- Coordinate with regulatory agencies and other external auditors to build trust and confidence in company quality systems.
- Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
- Work with the company’s external suppliers including clinical research organizations contract labs, and manufacturing organizations to ensure consistent quality and compliance.
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance to applicable SOPs and GxP regulations.
- Oversee the GxP compliance auditing program to fulfill regulatory requirements.
- Monitor and analyze quality metrics to identify areas for improvement and implement corrective actions as needed.
- Build a culture of quality, focusing the organization on our highest priorities
What you bring
- Bachelor’s degree in science related field.
- 12+ years’ experience in Quality/Compliance in the pharmaceutical or biotechnology industry.
- 2+ years’ experience as a functional head of a Quality department.
- Strong GxP knowledge in the pharmaceutical industry.
- Hands-on experience with implementing and managing Quality/Compliance systems and processes/infrastructure.
- Proven record of developing and maintaining successful working relationships with regulatory agencies.
- Flexibility to adapt to a rapidly changing work environment and manage competing demands.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to collaborate, build relationships, and influence teams to work towards common goals.
Compensation & Benefits
ShapeTX offers a robust benefits package, including but not limited to: Medical, Dental and Vision coverage for employees and their eligible dependents. We provide eligible employees with 12 paid Holidays plus a one week winter break at year end. We are proud to offer a competitive paid parental leave benefit, an annual employee stipend for employees to use however they choose, a Flex Paid Time Off program (allowing flexible PTO for vacation, sick leave, and other purposes) and Company paid Long Term Disability. Employees are eligible to enroll in our Company’s voluntary 401k plan, voluntary Life/AD&D and Voluntary FSA’s.
The salary range for this role is $184,000 - $276,000. The hired applicant's placement within the range is based on qualifications and professional experience. Additional compensation may include annual target bonus and/or sign-on bonus, equity grant and relocation bonus.
We aspire to Shape Life! not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences.