Sapience Therapeutics is a clinical-stage biotechnology company focused on discovering and developing peptide-based therapeutics to previously ‘undruggable’ targets for major unmet medical needs, particularly high mortality cancers. Sapience’s technology acts by disrupting specific protein-protein interactions required for the regulation of key oncogenic and immune-modulatory proteins at the transcriptional level, allowing for targeting of intracellular proteins previously viewed as 'undruggable' due to their lack of enzymatic activity or ligand binding.
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%.
Contact: Please send resumes to firstname.lastname@example.org
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