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QA Director, Clinical

New York, NY

Posted: 08/20/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2606

Job Description


The QA Director, Clinical will act as the CQA responsible leader in the US. The purpose of this role is to ensure that Quality Strategy and Quality Management System (QMS) related to Clinical operations is implemented, inspection ready and maintained in a state of control in compliance with applicable national and international GxP rules and regulations. The QA Director, Clinical will work directly with the VP Quality to ensure that company’ s quality KPIs, goals and objectives are tracked and trended, and that quality and compliance risks are identified, mitigated and, if needed, escalated. Member of the Quality Leadership Team.

Responsibilities include:
  • Responsibility for the QMS System, ensuring that it' s fully deployed, up to date and maintained in a state of compliance
  • Promote a “ Quality Mindset” with peers and stakeholders by providing proactive thinking and strong input and guidance to situations that arise that require in-depth knowledge of GCP regulations and QMS
  • Provide CQA oversight and support to Pre-Clinical and Clinical Operations conducted via the US team
  • Provide CQA oversight and follow up on 3rd party vendor and suppliers (CROs, CMOs, etc.) performance
  • Act as QA representative in project meetings providing input and guidance to ensure compliance throughout the project lifecycle
  • Act as QA lead on all clinical quality matters relating but not limited to regulatory submissions, clinical protocols and the conduct and reporting of clinical trials
  • Contribute to the selection of and ongoing auditing of key suppliers, vendors, CROs and CMOs
  • Support and/or execution of audits e.g: Site, vendor, process, systems, regulatory submission, clinical trial documents
  • Manage the Clinical Review Board in response to any identified serious complaints and/or quality incidents to assure all products meet safety and quality requirements, and the safety of subjects and patients is protected. When safety or quality issues are identified with products, assure processes are implemented to protect the safety of objects and patients
  • Prepare for, and host, successful regulatory inspections for GCP requirements. Ensure any findings reported in such inspections are appropriately remediated in a timely manner
  • Drive communication and interactions with global QA colleagues at other locations to ensure consistency in the application of the QA strategy and to promote standardization of within the business
  • Collaborate with US management and staff to assure appropriate performance of clinical studies which meet compliance and project requirements
  • Provide training and mentorship to the US team, develop and deliver awareness sessions on various GCP topics
  • Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents
  • Ensure own training is undertaken in a timely and compliant manner before the task is undertaken
  • Ensure own KPIs, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines
  • Can deputise for other members of the Global Quality Leadership Team

Requirements / Qualifications:
  • Science based degree e.g. BSc or MSc
  • Minimum 10 years’ experience working at senior management level in a pharmaceutical/biopharmaceutical Quality Assurance commercial and GCP function preferably sterile products
  • Extensive knowledge, and hands-on understanding and application of GCP and GMP regulations and substantial experience with defining and harmonizing Quality Management Systems combined with a proven track record of having successfully implemented these
  • Extensive knowledge and understanding of pharmaceutical Quality Assurance and GCP experience within a clinical trails and operations environment. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate and ensure that clinical trials (Phase I, II and III) are compliant with subsequent commercial manufacture and supply for effective and approved products.
  • Extensive knowledge and proven track record of implementing Quality Management Systems which are simple, robust and in compliance with applicable cGxP regulations and guidelines
  • Extensive knowledge and experience in auditing requirements – Lead Auditor for GMP (including sterile/aseptic manufacturing) & GCP
  • Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
  • Extensive knowledge of working with or within CROs/CMOs organizations
  • Knowledge of preparing for, hosting and follow up on regulatory inspections
  • Seasoned leader who has been part of Senior management teams and are able to contribute to the development and implementation of operational strategy of the company with emphasis on quality requirements, product development activities and commercialization
  • Ability to interpret complex data and present key findings
  • Must have a hands-on approach, and experience with building a “ Quality Mindset” for team members who has not worked within a GxP environment
  • Strong interpersonal skills, must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
  • Experience with hosting and follow up on corporate audits, client audits and regulatory inspections
  • No line management, might change in the future

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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