Manager, Clinical Quality Assurance

Responsibilities

• Collaborate with stakeholders, as needed, to gain up to date information for tracking key clinical QA activities (i.e., database reports, form completion, critical form review, inspection readiness).
• Manages and maintains electronic quality management systems in support of on-going clinical quality activities.
• Supports the conduct of external GCP audits of clinical service providers, CROs, and suppliers.
• Supports the conduct of Investigator site audits for applicable clinical trials.
• Supports the conduct of internal process audits for clinical and pharmacovigilance functions.
• Identifies and escalates significant compliance issues to clinical QA and relevant leadership, including the assessment of serious breaches. Supports investigations related to identified issues.
• Participates as member of clinical study teams for assigned Therapeutic Areas/Studies, in ensuring compliance with ICH-GCP and applicable policies and procedures.
• Establishes relationship with CRO Quality Team members (as applicable) for the ongoing review of quality and compliance issues.
• Supports presentation development for GCP training to Clinical functions based on identified needs.
• Contributes to data collection of audit and inspection trends and metrics for CQA monitoring, audits, investigations, updates and presentations.
• Timely completion of tasks and follows-up with status updates on open action items.
• Maintains and further develops expertise in international GCP regulations and internal policies and procedures (using reference material) that may impact drug development.
• Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or policy-related training (as required).
• Provide support and guidance during and following internal audits and external regulatory inspections (as required).
• Support Inspection Readiness program and make recommendations for its continuous improvement.
• Participate on quality and compliance initiatives, as assigned.

Qualifications

• Bachelor’s degree in scientific, health sciences or quality-related field.
• 3+ years in a pharmaceutical drug development GCP and/or Clinical QA related discipline.
• Trained and knowledgeable in international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH-GCP Guidelines.
• Previous experience managing quality and GCP compliance issues.
• Quality Certification and Clinical Supply QA Management experience is highly desirable.
• Experience with cross-functional stakeholder management.
• Strong knowledge of the drug development processes (Ph I – IV).
• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
• Ability to influence people and affect change.
• Ability to navigate and negotiate cross-functionally, in a matrix organization, to resolve conflicts.
• Ability to build and sustain meaningful relationships with business stakeholders and partners.
• Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance, and escalations.
• Strong project management skills including team leadership, consultative facilitation, risk analysis, follow-through, and project planning.
• Strong interpersonal and organizational skills; highly self-motivated, strong team-player, well-organized, confident, possesses a solution-oriented mindset and able to develop innovative solutions to issues.
• Strong verbal and written communication skills; detail oriented, uses discretion and critical thinking skills.
• Strong computer literacy in MS Word, Excel, Project, Visio, PowerPoint, Clinical and Quality databases.