Senior/Quality Assurance Manager – 1 US based, 1 Australia based

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Posted 2 months ago

Senior/Quality Assurance Manager – 1 US based, 1 Australia based

Reports to: Head of Quality

Why you are here

As a clinical quality expert with solid knowledge and understanding of the drug development process, you will be responsible for the effective implementation of quality strategy at GreenLight Clinical to ensure our sites, functions, processes, systems, and suppliers comply with the applicable SOPs, regulatory requirements and current industry standards and practices.

You will lead QA programs, policies, and procedures cross-functionally to ensure GxP quality and compliance. This encompasses working closely with the clinical study team to develop risk-based internal processes and systems related to GxP QA activities and advance quality outcomes of clinical projects entrusted to GLC.

You will contribute to the oversight and the implementation of proactive compliance and risk management as well as advancing QA’s capabilities to meet future business needs.

You will lead QA programs, policies, and procedures cross-functionally to ensure GxP quality and compliance. This encompasses working closely with the clinical study team to develop risk-based internal processes and systems related to GxP QA activities and advance quality outcomes of clinical projects entrusted to GLC.

You will contribute to the oversight and the implementation of proactive compliance and risk management as well as advancing QA’s capabilities to meet future business needs.

What you will deliver

An effective, efficient, and fit for purpose clinical quality system that stimulates:

  • A Quality Culture and continuous learning environment
  • Compliance with regulatory requirements, current industry standards, and best practices.
  • Proactive risk, issue, and knowledge management and process improvements
  • Document control, and documentation that supports the achievement of quality
  • Engaging partnership with internal and external collaborations with sponsors and suppliers
  • Independence of internal and external audits

How we will measure it

  • Effectiveness of risk-based internal and external audits
  • Early identification and reporting of major/critical risks and issues
  • Quality of root causes analysis and CAPAs in preventing issue recurrence
  • Value generation from key trends, data insights, and impact assessments
  • Inspection readiness of GLC clinical programs
  • Feedback from internal and external stakeholders

What you are responsible for

 Risk-based Auditing program:

  • Develop and implement risk based GxP quality assurance including performing risk assessments, identifying audit targets, performing audits and where applicable, working with contracting external consultants to conduct audits, preparing/reviewing the audit reports, as well as CAPA, needed within the stipulated timelines. Host external audits and lead on-site or remote audits. Assist with the training of new / less experienced auditors when required by performing co-audits, coaching, training, and sharing of knowledge, experience, and best practices.

Issue and Risk Management

  • Enable end-to-end management of issues and risks. Lead/participate/support pivotal quality and compliance-related projects and/or initiatives. Guide non-compliance investigation, root cause analysis, impact assessment and develop an appropriate CAPA Plan consistent with the level of impact on patient safety, rights, and well-being; data integrity and/or scientific rigor; compliance with regulatory requirements. Escalate and manage the mitigation of critical risks, issues, and serious breaches as required per Standard Operating Procedures. Track CAPA Plan, actions, and effectiveness checks until closure.

Trend Analysis and Data Insights

  • Perform and report on trending and analysis of non-compliances, audits, inspections, customer feedback, product complaints, changing regulations, and performance metrics (KQIs and KPIs) that impact GLC’s QMS components and processes. Communicate risks of projects and programs to relevant stakeholders, provide actional insights and develop and implement risk mitigation measures. Prepare Quality reports, conduct and follow-up on Quality Management Reviews. Explore future trends and identify opportunities for continuous improvements.

Learning and SOP Management

  • Support functions to conduct learning analysis, identify training needs, and design role-based learning matrix/curricula. Translates knowledge of current industry trends, standards, leading practices, and methodologies of Good Clinical Practice (GCP) into the development and improvement of GLC processes/learning to ensure current procedures/learning continue to add value and are relevant to the changing business environment. Contribute to cross-functional learning/SOP discussions and reviews to identify synergies and efficiencies across GLC. Adhere to principles of GLC’s SOP requirements and compliance standards as an author of Clinical QA SOPs.

Vendor Management

  • Manage GxP supplier quality program, conduct supplier risk assessment, manage an approved list of GxP suppliers, perform supplier qualifications/audits, execute quality agreements, monitor supplier performance as well as establish key vendor oversight plans and processes. Support the functions to define the metrics for the determination of vendor quality performance, monitor the quality metrics for identified vendors, and review trends in vendor quality deliveries. Represents Quality on relevant Vendor Governance meetings where needed.

Inspection

  • Collaborate with internal and external stakeholders to build and maintain inspection readiness programs (including training and tools) that enable consistent management across GxP inspection types. Lead cross-functional inspection preparations, risk assessments, the conduct of mock inspection, pre-inspection visits, preparation of event histories, and SME training. Serve as a front room or backroom host when needed, including the provision of GxP-related technical support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions

Other

  • Maintain quality documents owned by Quality and perform other duties
  • Any other tasks as assigned in response to changing business conditions and/or requirements.

Qualifications

  • Bachelor’s degree in life science as a minimum
  • Quality assurance professional certification is a plus

Work experience

  • Minimum of 8 years of clinical research experience in a pharmaceutical or CRO environment.
  • Experience in smaller organizations supporting a novel biopharmaceutical company or boutique CRO preferred
  • Experience in auditing a broad range of internal and external clinical GxP audits and in compliance and quality trend data analysis
  • Significant experience of interacting with Regulatory Authorities e.g., regulatory inspections
  • Familiarity with computer system-related validation, 21 CFR Part 11 electronic systems, and compliance is a plus.

Technical knowledge & skills or other requirements

  • Possess a current and strong working knowledge and interpretation of ICH Guidelines and United States Code of Federal Regulations and governing clinical research.
  • Possess strong critical thinking skills with the ability to translate complex issues into a meaningful set of recommendations.
  • Possess interpersonal and communication skills (verbal and written) to work collaboratively within a dynamic, multi-cultural cross-functional matrix team consisting of internal and external partners in a fast-paced environment.
  • Excellent organizational and planning skills to lead projects and work on multiple priorities.
  • A self-starter and capable of working independently with minimal oversight. Willing to provide training and coaching to junior staff.
  • Able to travel.

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