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Associate Director/Director, Quality Assurance

Cambridge, MA

About Theseus

Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): “pan-variant” targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn.

Role Description

The Associate Director/Director, Quality Assurance is responsible for the strategic development and operational management of Theseus’s quality assurance program. The individual will support Good Clinical Practices (GCP) and Pharmacovigilance (PV) as well as manage and collaborate with external consultants/contractors, as necessary, to support QA activities in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).  In addition, this role will be accountable for the execution and administration of the Quality Management System in support of the GxP functions, and quality compliance at Theseus and its vendors in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The Associate Director/Director, Quality Assurance will build relationships with external consultants/contractors, as necessary, to support QA activities and responsibilities, and will provide guidance to the organization on global quality matters. At minimum, this position requires expertise in current GCP and PV Quality relevant regulations. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor Audits and Regulatory Inspections, and that the appropriate processes, systems, and activities are in place and performed to protect patient safety, product quality, and data integrity. The successful candidate will drive, promote, and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.

Responsibilities

  • Provide direct Quality Assurance oversight of GCP and PV activities at Theseus, its investigator sites, and its contract research organizations for clinical studies.
  • Collaborate with and/or manage external consultants/contractors with GLP and GMP expertise to provide Quality Assurance oversight of GLP and GMP activities related to nonclinical studies and CDMO vendors.  
  • Develop and implement risk-based Quality strategies including establishment and maintenance of phase-appropriate quality systems; proactively identify and mitigate quality risks.
  • In collaboration with function heads and external Quality Assurance consultants/contractors, ensure GxP vendors comply with the applicable quality program and regulations/guidelines and are prepared for Regulatory inspections.
  • Ensure that quality metrics comply with best industry standards and practices.
  • Maintain an effective Quality governance and continually improve governance to meet business and compliance needs.
  • Led by functional representatives and external Quality Assurance consultants/contractors, ensure the development, implementation, and maintenance of Quality Systems and SOPs related to GxP activities.
  • Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations.
  • Ensure vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.
  • Ensure pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities. 

Qualifications

  • Bachelor's degree or higher in related Life Sciences discipline.
  • 10 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5+ years of experience in Clinical Quality Assurance function for development stage activities.
  • Strong working knowledge of GCP and PV Quality requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.
  • Strong working knowledge of Quality Management Systems (QMS)
  • Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
  • Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
  • Strong interpersonal/communication skills. Prior success in working effectively with senior scientific, medical, and operations staff.

Candidates should be aware that Theseus Pharmaceuticals requires all employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Theseus is an equal opportunity employer and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Theseus Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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