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).
Reporting to the President of R&D, the Head of Quality Assurance is responsible for the strategic development and operational management of Theseus’s quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support Good Manufacturing Processes (GMP), Good Laboratory Practices (GLP), Good Clinical Processes (GCP), and Pharmacovigilance (PV) Quality compliance in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The scope of this leadership role includes ensuring GMP, GLP, GCP, and PV compliance and quality systems at Theseus and its vendors. The Head of Quality Assurance will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current GMP, Good Clinical Practices GCP, PV Quality and GLP and 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.
- Lead a group that provides Quality Assurance oversight of GMP, GLP, GCP, and PV activities at Theseus and its investigator sites and contract research organizations for clinical and nonclinical studies, PV vendors, and CDMO vendors.
- Develop and implement risk-based Quality strategies for investigational and commercial materials including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.
- Be responsible for Manufacturing, Clinical and Nonclinical quality-related activities and requirements to enable the quality management system; planning and supervise vendor, internal, and site audits; supporting teams during health authority inspections; and providing guidance on quality issues.
- In collaboration with function heads, ensure GMP/GLP/GCP/PV vendors comply with the applicable quality program and regulations/guidelines and are prepared for Regulatory inspections.
- Ensures quality metrics comply with best industry standards and practices.
- Maintains an effective Quality governance and continually improve governance to meet business and compliance needs.
- Led by functional representatives, ensure development, implementation, and maintenance of Quality Systems and SOPs related to GMP/GCP/PV 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 Technical Operations and GCP/GLP/PV vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.
- Stay abreast of industry developments – forthcoming regulations, guidance, best practices, etc., training, and mentoring staff on global GMP/GLP/GCP/PV regulations and guidance.
- Ensure pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities.
- Bachelor's degree or higher in related Life Sciences discipline.
- 15 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5+ years leading a Quality function for development stage activities.
- Strong working knowledge of global GxP 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.
- Proven track record in establishing a quality organization and managing GMP/GCP Quality staff.
- Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
- Demonstrated success leading and motivating cross-functional teams and managing direct reports.
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff.