Director, Quality Assurance (cGXP)

THE COMPANY

Septerna is a biotechnology company with a vision to become the industry-leading G protein-coupled receptor (GPCR)-focused R&D company with a portfolio of life-changing medicines. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures. For more information see: www.septerna.com.

Join a multidisciplinary team of colleagues focused on creating revolutionary medicines to address significant needs of patients. Bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to our mission. At Septerna we embrace diversity of thought, expertise, and background; we share a fearless pursuit of ground-breaking innovations; and our employees learn from each other and succeed as a team.

As a member of the Development Sciences team, you will be responsible for the development, implementation, Administration, and management of the company’s quality assurance functions. This person will report to Senior Vice President, Development Sciences.

*Title commensurate with experience

QUALIFICATIONS

· Directs the quality assurance functions and assures cGXP compliance.

· Assures that all contractors, company affiliates and external CMOs/CROs, maintain Quality Systems in compliance with FDA and applicable international Health Authorities cGXP regulations.

· Leads the development and implementation of the quality plan in accordance with the mission and strategic goals of the organization, federal laws and regulations, and quality standards.

· Develops, implements, and maintains the quality documentation system.

· Develops and implements systems, policies, and procedures for the identification, collection, and analysis of performance measurement data; presents results to the management leadership team and suggests improvement strategies, as applicable.

· Provides leadership and direction to the company by the establishment of strategic initiatives to ensure the organization maintains a state of GxP compliance and inspection readiness.

· Works collaboratively with other departments to ensure the establishment and implementation of policies and procedures that are compliant with GxP regulations and safety procedures.

· Reviews and approves completed batch records, test results, investigations and change controls, clinical protocols and study reports, and nonclinical protocols and reports.

· Final release authority for all clinical and commercial products

· Manages the internal and external audit program.

· Manages the cGxP training program.

· Responsible for the validation program.

· Maintains strong relationships with regulatory agencies, as it relates cGxP, competent authorities and standards organizations which impact the company.

· Represents the organization during third-party audits and inspections.

· Manages discrepancy reporting, corrective and preventive action (CAPA) and change control systems.

· Maintains professional and technical knowledge by attending educational workshops, establishing personal networks, and participating in professional societies. Performs all other related duties as directed by supervisor.

· Reviews changes to global quality/regulatory requirements and industry best practices and facilitates implementation through new or revised processes.

· Other duties as required.

MINIMUM QUALIFICATIONS

· B.S. or higher in a scientific discipline, preferable biology, or chemistry

· 12+ years relevant pharmaceutical or biotech experience in a quality assurance role.

· Expert knowledge of cGxPs regulations and guidance for the manufacture of biological, or pharmaceuticals products and a keen understanding of how the regulations are applied to the manufacture, testing and release of product.

· Experience in cGXP regulatory requirements.

· Previous QA management responsibilities.

· Must have experience auditing to cGxP regulations.

· Must have experience in generating SOP’s.

· Previous experience developing a quality system and development of corporate level policies and procedures.

· Previous leadership and staff development experience.

· Excellent communication and negotiation skills; ability to work collaboratively within and across functional groups.

· Strong verbal and written communication skills, proven ability to translate technical documentation into effective quality strategies.

· Good project management skills.

· Experience working directly with the FDA, Notified Bodies, and other governmental agencies on Quality matters on a global basis.

The anticipated salary range for candidates who will work in South San Francisco, CA is $210,000 - $235,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.