Associate Director, Quality Assurance« Go Back
Employment Status: Full-Time
About Sapience Therapeutics
At Sapience, we think boldly about the possibilities for treating cancer. We aim to discover and develop peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. To accomplish this goal, we are developing next generation peptide therapeutic candidates called SPEARS (Stabilized Peptides Engineered Against Regulation) to drug oncogenic transcription factors and regulatory pathways of disease that make cells cancerous or dampen the immune systems response against tumors. Our lead compound, ST101, is currently in the Phase 2 portion of a Phase 1/2 clinica trial and has demonstrated clinical proof-of-concept in cutaneous melanoma and recurrent GBM.
Sapience is currently seeking an Associate Director of Quality Assurance to join our growing biopharmaceutical company developing peptide-based therapeutics for major unmet medical needs, including high mortality cancers. Sapience currently outsources clinical development activities and this position will play a key role in the quality management of external partners.
- Development and maintenance of GXP quality systems and procedures that ensure compliance with established standards and agency guidelines (FDA, MHRA EU, ICH).
- Represent Sapience Quality both internally (e.g., clinical operations, regulatory, CMC, non-clinical) and externally (e.g., CRO’s, Vendors, Investigator Sites).
- Manage and maintain the vendor qualification process (GLP, GCP, GMP) including audits.
- Initiate new, revise existing, and conduct training of SOPs.
- Ensure documents are reviewed for completeness, accuracy, and conformance to GXP procedures and internal SOPs.
- Perform QA review of cGMP-related documentation, such as specifications, test methods, validation and technical protocols and reports, stability protocols and reports, master and executed production records, deviation/investigation/out-of-specification reports.
- Perform Quality investigations of events or deviations.
- Support development and maintenance of Quality Agreements with suppliers/partners.
- Manage quality systems such as document control, training, CAPA, and change control.
- Participate on cross-functional teams in support of new drug product development.
- Perform ad-hoc work/special projects as necessary to support Sapience Therapeutics.
- Bachelor’s Degree or higher in biology, chemistry, or related life-sciences discipline; Master’s Degree preferred.
- Minimum 8 years of experience in quality assurance or related field within the pharmaceutical or biotech industry experience and at least 5 years of direct experience in GXP.
- Thorough knowledge of global rules, regulations, and guidances governing quality and safety of drugs and biologics in all phases of clinical development.
- Excellent communication skills required, both verbal and written.
- Effective leadership, negotiation, and conflict resolution skills.
- Strong attention to detail with ability to analyze, interpret, and solve complex problems.
- Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced team environment.
- Strong time-management and organizational skills with the ability to be flexible to meet set goals and timelines.
- Strong knowledge in standard software including MS Office Word, Excel, and PowerPoint.
- Full COVID-19 vaccination required.
- This role can be remote, but local candidates are preferred.
- Position may require some limited travel, 5%.
What We Offer
- A diverse and inclusive culture where ideas are shared and your authentic self is welcome
- Exceptional, collaborative, dedicated team
- The chance to participate in work which may have a transformational impact on millions of people
- Continuous learning and dynamic challenges to help you grow and be the best version of yourself
- Comprehensive health/dental/vision insurance, 401k match, stock options, PTO
How to Apply
To apply online, please fill out the form below. If you prefer to send a letter, resume or curriculum vitae to email@example.com please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.
Sapience Therapeutics is an equal opportunity employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds.