TARIS Biomedical is a unique therapeutically -focused urology company developing drug -device combination products f or the treatment of genitourinary diseases.
Position: Associate Director – Clinical Quality Assurance (GCP)
Reports to: Sr. Director, Quality Assurance
Associate Director Clinical Quality Assurance is responsible for internal and external Clinical QA Activities to support Clinical quality assurance program and quality systems. This includes QA review of clinical trial documents, data integrity assurance, GCP compliance at clinical sites and internally, clinical vendor (CRO) audit, CRO qualification and management, internal and external GCP quality audits, PAI inspection readiness and supporting clinical CAPA.
This position will assure clinical quality assurance activities internally at TARIS and ensure documentations is appropriate, and critical service providers such as CROs, test labs and clinical sites are compliant to GCP. Primary function of this position is to provide the daily hands on support to the organization with respect to TARIS’ internal clinical QA and external facing Quality assurance. This is a critical role to TARIS because it fills in the critical function within the Quality department, i.e. a hands-on external focused Quality representative to perform the critical functions of clinical compliance, clinical quality assurance and clinical vendor management and control.
Key responsibilities of this function include management and control of activities at key vendors like the CROs, biometrics and data management vendor, Safety database vendor, labeling and distribution etc. These subsystems need substantial sponsor oversight during the formative stages. This function will also support phase II requirements such as PAI inspection preparation, readiness and quality representation.
This position will participate on clinical process improvement projects and initiatives, supporting departmental and corporate quality goals and priorities, while ensuring products, processes and systems effectively meet expectations of TARIS’ Quality Assurance and Overall Business from a clinical development GCP compliance perspective from concept through commercialization. The successful candidate will be a seasoned professional with experience in clinical quality assurance, clinical research management, data management and clinical quality assurance function in a clinical stage pharmaceutical or combination product organization.
GCP QA will provide advice on the interpretation and application of the regulatory requirements. Provide Clinical researchers advice in resolving non-compliance issues in a professional and pragmatic way. This individual will be responsible for both auditing and providing guidance on GCP. The individual also acts as a GCP quality adviser to the functions involved in the drug development process and providing ‘trouble-shooting’ advice and interpretation of regulations and guidelines.
- Support internal and external organizations:
The GCP QA professional will identify areas for improvement and update procedures and policies related to GCP practices. Interact with different groups within the organization and outside including clinical research, outsourcing/contracts, IT, data management and biostatistics, clinical trial supplies, pharmacovigilance, regulatory affairs, SOP management groups and training functions. Externally, GCP QA professional will interact with a diverse range of groups such as third-party service providers, CRAs, Investigators, Study Nurses and other study site personnel, and in the event of inspections the regulatory inspectors.
- Auditing and Report Writing:
The type of audits that may be conducted includes: Third party service providers; Clinical trial sites; Quality Systems audits; Documentation audits; Computerized systems; Inspection preparation.
Detailed Description of responsibilities:
This position provides the essential, hands-on day-to-day support to the organization, specifically to the TARIS Quality management in CRO management, internal GCP compliance and preparation of key activities leading to PAI inspection, for example preparation, oversight and control to ensure PAI Inspection readiness, vendor oversight management, vendor investigation, deviations and CAPA.
- Participates on clinical project teams and influence and encourage clinical teams towards a state of inspection readiness at all times.
- Consultant support for compliance and regulation questions including quality review of clinical study documents
- Participates on clinical process improvement projects and initiatives, supporting departmental, divisional, and corporate quality goals and priorities.
- Facilitate Inspection Readiness program to include inspection readiness training and facilitate/coordinate Mock BIMO inspections.
- Manage/coordinate BIMO sponsor inspection, and other regulatory agency sponsor inspections of offices.
- Preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
- Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
- Clinical Quality System: Support to the Clinical organization in meeting
- Quality system requirements: Support Clinical and QS team during External Regulatory/Notified Body audits.
- CAPA program; assessing internal noncompliance working cooperatively with CAPA owners providing quality input.
- Independent Auditing: Plans, schedules, and conducts external quality audits to assure that clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
- Plans, schedules, and conducts internal quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
- Plans schedules and conducts clinical vendor assessments, qualification and periodic. Review, revise, update and maintain Clinical AVL
- Communicates observations to clinical investigators, clinical program managers, directors, and management.
- Contributes to the development of audit procedures and processes.
- Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
- Bachelor’s degree, minimum 8 years of experience in Clinical QA Activities in a quality-related clinical product development organization in a pharmaceutical/biotech/medical device industry.
- Clinical Quality Assurance with minimum of 2 years in people management preferred.
- Demonstrated knowledge of GCP, Clinical compliance and Auditing within an FDA-regulated and global environment. Solid understanding of global clinical development and robust experience on GCP-ICH, audits and inspections. Clinical Compliance, QMS principles, GCP/ICH guidelines.
- Experience with Clinical Operations Governance and Execution (in & outsourcing) – Phase 1 to 3 Clinical Trial Management. Experience with electronic trial systems, quality management systems, eCRF systems preferred
- Excellent organizational and time management skills with a strong attention to detail. Strong interpersonal communication skills; acts with urgency and passion. Enjoys helping others Ability to work both independently and with a team in a collaborative, fast-paced setting.
- Up to 25% Travel is required for this position.
To apply, please send your CV to firstname.lastname@example.org