Associate Director/Director, Clinical Quality Assurance (Qa)

Associate Director/Director, Clinical Quality Assurance

PURPOSE OF JOB:

Seeking an Associate Director/Director, Clinical Quality Assurance (QA) reporting to the SVP of Regulatory Affairs and QA.
The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU, and global requirements. The position involves managing and participating in global Clinical Quality operations and liaison of Clinical Quality-related issues with related functional departments.

The candidate must have experience reviewing and collaborating on regulatory submissions as well as hosting and facilitating regulatory inspections. The ideal candidate has a quality mindset in global clinical development and oversees Clinical Quality activities including but not limited to inspection readiness, and internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage Clinical QA activities while being an advocate to drive a quality and regulatory compliance culture.

In addition, the candidate must actively manage programs to an appropriate level of inspection readiness in collaboration with clinical stakeholders and act as a catalyst for continuous process improvement.

MAJOR DUTIES AND RESPONSIBILITIES:

• Develop and implement GCP, GLP quality systems in accordance with ICH, FDA, EMA, and global competent authority regulations and industry guidance.
• Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols, and procedures.
• Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities, and internal departments.
• Lead and ensure inspection readiness activities for all internal and external entities.
• Lead and host GCP, GVP, and GLP inspections. Follow up to any responses and CAPAs.
• Conducts audits at clinical trial sites and Contract Research Organizations to ensure compliant conduct of sponsored clinical trials.
• Develop, implement, and manage the deviation and CAPA systems.
• Responsible for writing and maintaining GCP SOPs and providing associated training.
• Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.
• Develop and implement overall GCP strategy, performance metrics, analytics, and reports.
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards.
• Represent Clinical QA on assigned projects and study/program team meetings to anticipate and address quality issues that may arise, including identification and resolution. Be an advocate for quality and regulatory compliance.
• Build positive professional relationships and trust with team members, colleagues, external contractors, vendors, consultants, and regulatory authority contacts.
• Participate in the recruitment, performance, and management of staff in Clinical QA, including coaching, career development, and oversight of work.
• Effectively communicate compliance related metrics, risks, and compliance challenges to senior management.
• Support continuous improvement planning.
• Communicate and promote a culture of quality and regulatory excellence.
• Up to 10-15% travel may be required.
• Other duties as assigned.

EDUCATION:

• A Bachelor's degree in a scientific or technical discipline is required.

EXPERIENCE REQUIREMENTS:

• A minimum of 7+ years of experience in GxP and Quality Systems in a biotechnology or pharmaceutical environment is required.
• Proven, extensive knowledge of worldwide GCP regulatory requirements, industry practices, and ability to apply concepts.
• Experience with GCP, GVP, and GLP.
• Experience with electronic Quality Management Systems and Trial Master File.
• Experience in developing and maintaining QA systems.
• Experience working with CROs.
• Develop teams to engage collaboratively and constructively.
• Experience leading/hosting US and international health authority inspections/interactions.
• Experience in crafting and implementing quality systems and risk management tools.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Experience managing direct reports, including coaching and career development.
• Strong teamwork, collaboration, and management skills.
• Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities.

OTHER QUALIFICATIONS:

• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Highly responsible, self-motivated professional with enthusiasm and passion for the work.
• Sense of urgency in performance of duties.
• Highly proficient with various Microsoft and other computerized systems (Word, Outlook, Excel, PowerPoint, Visio, Veeva, Audit Utopia, etc).
• Interpersonal skills that promote a collaborative and productive environment.
• Effective and efficient written and oral communication skills.

PRECISION LIFE SCIENCES