Summary of Position:
Responsible for the execution of the ArriVent Quality Systems, Operations and associated support processes and will interface directly with 3rd party vendors, Technical Operations, Regulatory, Clinical Development and Clinical Operations teams to support and achieve Quality and Compliance goals. Some interface and influence of leadership is required with input on key global QA / Compliance and business initiatives. Responsible for the monitoring of external regulatory compliance environment and making recommendations to Management on tactical issues impacting ArriVent business.
Position includes the following: GxP Auditing of internal and external services utilizing risk-based strategy; Managing Document systems; Change management utilizing a risk-based approach and root cause analysis. Implementing and utilizing Quality Management tools (Paper/Electronic system). Product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems, and assists in facilitating regulatory compliance inspections. Approve SOPs, batch record and deviations. Strong time management skills. Host and manages Regulatory and 3rd party audits. May travel internationally and interact with regulatory organizations.
- Manage and implement GxP Quality systems including oversight and management of trial master file, SOPs, training, and audit program
- Provide strategic direction for electronic quality system setup and configuration
- Collaborate and establish, maintain procedures with technical teams to ensure that clinical supply and manufacturing activities are conducted in compliance with applicable GxP requirements.
- Host and manages Regulatory and 3rd Party Audits
- Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of, bulk substance, drug product, packaged and labeled drug products.
- Lead investigations for any non-conformances during GxP activities
- Manage the review and release of all products for which the ArriVent holds the IND or equivalent investigational application.
- Lead and conduct GxP audits on suppliers, issue audit agendas, reports, findings, perform follow-up actions and escalate findings to management, as necessary.
- Oversee GCP compliance with respect to clinical site and CRO audits
- Oversight, management, and qualification of all GxP vendors
- In conjunction with Clinical Operations management, assures appropriate oversight of clinical trial execution
- Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP, GLP, and GCP
- Maintain compliant quality system that adheres to FDA regulatory expectations both internally and with respect to oversight of the company’s vendors
- Work with CMC, Clinical, Regulatory, etc as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and regulatory inspections to ensure that the organization is inspection ready
Desired Skills and Experiences:
- 7 years of experience with increasing levels of responsibility within the Quality and/or Compliance area. This includes hands on experience with managing inspections within the Clinical and R&D areas
- Knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.
- Compliance / QA experience at a pharmaceutical / biopharmaceutical
- Extensive experience with GxP systems approaches and implementation of such systems
- Proven ability to work in a collaborative team environment across multiple technical functions.
- Ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third party vendors.
- Strong project management and organizational skills.
- Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).
- B.S. in Biology, Chemistry, Engineering or related fields preferred.