Job Listing

Manager/Associate Director of Quality Assurance

Employment Status: Full-Time

Company Overview: www.sapiencetherapeutics.com

About Sapience Therapeutics

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.

The position:

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.

Responsibilities:

  • 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.

Qualifications:

  • 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 careers@sapiencetherapeutics.com

To Apply

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc

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