Clinical Quality Compliance Lead

Job Duties:

• Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
• Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
• Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to values and strategic priorities.
• Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.
• Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan.
• Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency.
• Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.
• Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively pro-vides strategic and tactical directions in the mitigation.
• Hosts GCP inspections and provides strategic direction to relevant functions and Subject Matter Experts (SME).
• Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks.
• Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities.
• Effectively and timely escalates to management.
• Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submit-ted on time.
• Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed.
• Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late.
• Mitigates and escalates any risks.
• Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs.
• Provides input to the effectiveness check plans and reviews and approves outcome.
• Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control.
• Represent Clinical Quality Compliance in these topics in inspections.
• Support and provide relevant guidance to other non-GCP specific inspections (e.g., GVP, GMP, etc).
• Leads complex quality investigations impacting the clinical trial delivery systems.
• Provide Quali-ty Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
• Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management.
• Leads cross-functional continual improvements projects that enable a compliant quality system in the clinical trial delivery quality systems.
• Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
• Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management.
• Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
• Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI).
• Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely.
• Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs).
• Contributes to any relevant quality and compliance governance, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.
  
  

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.
• Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.
• Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
• Skilled in managing global, cross-functional projects.
• Fluency in written and spoken English, additional language skills a plus.
• Clarification, GCP/GLP/GVP auditing experience needed
• GXP
  
  

Job Duties

• Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies
• Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees
• Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies
• Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality
• Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and policies and procedures.
• Audits require advanced auditing skills and may involve technically complex assignments.
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.
• Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
• Lead and/or support quality governance council meetings
• Liaise and collaborate with internal and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives
• Analyse, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation.
• Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
• Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Lead process improvement initiatives as requested by management
• Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk
• Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP
• Audits require advanced auditing skills and may involve technically complex assignments.
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.
• Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
• Lead and/or support quality governance council meetings
• Participate in GCP health authority inspections, as required
• Mentor and provide support to Manager level CQA personnel
• May act as supervisor for temporary contractors
  
  

Qualifications:

• BA/BS degree required
• Advanced Degree preferred.
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 7 years of GCP-related Quality Assurance experience.
• GXP
• Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development.
• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
• Strong technical writing skills; able to write quality positions, audit reports, and procedures.
• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Superior attention to detail and ability to analyze complex data.
• GCP Quality Assurance registration/certification preferred.
• Routine demands of an office-based environment.
• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
• Requires approximately 30% travel.
• Clarification, GCP/GLP/GVP auditing experience needed
  
  

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.