Director of QA / QC
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm, a BridgeBio company, is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. Topical patidegib gel has shown early promise in a Phase 2 clinical study in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. Topical patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials, but without the adverse systemic side effects of oral hedgehog inhibitors. Patidegib’s gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome.
Reporting to the VP of Technical Operations and Program Management, the Director of QA/ QC is responsible for the development, implementation, and management of PellePharm's internal and external quality strategy and Quality Systems to achieve compliance with company standards, GXP, and FDA regulations and guidance. The Director will oversee and approve quality standards related to the manufacturing, testing, and release of clinical trial materials and eventually commercial products. This individual is also responsible for the execution of development analytical testing oversight of multiple contract testing laboratories and Contract Manufacturing Organizations (CMOs) and is the primary site of technical expertise for method development, validation and transfer. The Director of QA/ QC is also responsible for interacting with Executive Management, external suppliers, CMOs to ensure compliance in manufacturing, testing, and release of API, CTM, and commercial drug products and CROs to ensure the compliant conduct of clinical investigations. The Director of QA/ QC is the primary interface with FDA and other regulatory agencies on quality issues and during inspections.
Specific responsibilities of the incoming Director of QA/QC:
- Act as the company authority for the interpretation of GMP regulations and guidance documents related to pharmaceutical manufacturing.
- Primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs and CROs, and suppliers.
- Responsible for the release (or rejection) of products
- Responsible for setting quality policy and approving GXsP standards
- Responsible for the design, management and continuous improvement of all quality systems
- Manage internal and external audit programs for all GXP activities.
- Domestic and International Travel: up to 25%
PellePharm seeks a broadly developed team player with demonstrated Quality and QC experience with complex manufacturing programs. We have a strong preference for candidates with experience interacting with both domestic and international CMOs.
Given the “small biotech” nature of the Company, cultural fit of the successful candidate is an important criterion for his/her success at PellePharm. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude and an entrepreneurial spirit.
Specific Qualifications Include:
- Bachelor’s degree in a scientific field
- Minimum 10 years’ experience in GMP environment with at least 5 years QA and QC leadership experience, respectively
- Experience with manufacturing commercial pharmaceutical products is strongly desired
- Prior experience with outsourced GMP activity is critical and experience with administration of GCP systems is preferred
- Solid and demonstrable knowledge and understanding of US and international (e.g. EU, ICH) GXP regulations, procedures, and guidelines
- Recent experience in preparation of CMC sections of US and EU regulatory filing is highly desirable
- Understanding of pharmaceutical stability requirements and applications
- Proficiency in software such as Word, Excel, statistical data analysis programs etc.
- Strong oral and written communication skills
- Strong problem solving and organization skills
- Good collaborative skills