Description: Head of Quality Assurance and Compliance
Summary:
The Head of Quality Assurance and Compliance will lead the strategy and effective operations of
quality and compliance. This person will work in partnership across the Clinical and other
groups within Cara Therapeutics to ensure alignment, coordination and delivery of corporate,
and local quality and compliance goals.
Responsibilities:
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Leads the oversight of all GCP and GMP quality and compliance activities across Cara.
Provides recommendations for risk mitigation, continuous improvement and/or issue
resolution
Develops an overall risk assessment strategy that aligns with the Cara corporate risk
management strategy, and ensures timely, effective, and consistent execution of the risk
strategy, including mitigating risk
Ensures that issues/risks/trends/process improvement opportunities are appropriately
communicated back to the business partners, and effectively addressed
Ensures that effective GCP and GMP quality processes and SOPs are in place for each
Cara functional area
Ensures appropriate quality and compliance metrics are in place, are being measured, and
are being consistently tracked and reported on
Provides quarterly reports for Senior Management review on the status of compliance,
and quality standards of all facilities, processes, procedures and practices
Ensures clinical quality and compliance related records are current, and oversees training
compliance
Accountable for leadership, strategic oversight and expert input on all quality and
compliance issues arising on clinical studies (identified via audits or otherwise) and
ensures appropriate corrective and preventative action plans are defined and implemented
Accountable for establishing and maintaining a GCP training matrix relevant for each
applicable job role, optimizes the use of training tools (e.g. LMS, CHRIS) and evaluates
training compliance for GCP and GMP related topics across the business
Co-Lead/Lead all Good Clinical Practice (GCP) inspection readiness meetings, attend
functional department meetings and Study Management team meetings to ensure
inspection readiness activities and expectations are communicated in a timely manner
Works with Clinical Study team members to provide support and to ensure inspection
preparation deliverables are met per required timelines
Prepares Inspection Management Plans that include activities to build inspection
readiness into the development process (e.g. conduct study start-up inspection ready
assessments)
Co-lead/Lead all communications and inspection preparation training for vendors and
sites
Identifies gaps and issues and works with team(s) to develop CAPAs and/or strategies to
mitigate risks during inspections
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Assists with inspection preparation (mock interviews/inspections, training, preparation
visits)
Assists the Clinical and vendor Quality Auditing teams in preparation, conduct and
tracking of issues for Site Inspection Readiness
Leads the “ready room” for GCP and Post Marketing Surveillance inspections
Communicate lessons learned/best practices across the company
Provide expeditious inspection updates/daily summaries to Senior Management during
regulatory inspections
Ensure follow-up on all inspection commitments, responses, post-inspection activities,
corrective and preventative actions, and resolve all conflicts for timely closure
Facilitates and assists Departments and Clinical Study teams in developing Corrective
and Preventative action (CAP A) plans as a result of QAA audits (Site, Vendor and
Process Audits)
Tracks audit response and respective CAPA closure for audit Findings
Leads Suspected Serious Non-Compliance Investigations as needed.
Assists in tracking and trending compliance of CROs, Vendors, Sites, and Sponsor
(Quality Risk Management Indicators).
Provides support and guidance to Clinical Study Team on GCP compliance issues
Assists with Vendor Management Process, as needed, in conducting Functional area
assessments (e.g. SOP Comparisons)
Performs root cause assessments and trends study level activities from audits,
inspections, escalations, quality control measures, etc. in conjunction with Clinical Study
Team members and others as applicable.
Facilitates evaluation, investigation and corrective/preventative actions of unplanned
deviations of Procedural Documents and/or internal processes.
Requirements:
A Life Sciences graduate degree preferred, along with 10 years of experience in Clinical Quality
and Compliance management. Should have 15+ years of experience in clinical or pharmaceutical
development, including clinical operations and/or QA.
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Demonstrated people leadership skills. Significant experience and success track record of
line and cross-functional team management.
Ability to influence effectively in a matrix environment.
Recognized as a leader in the field of clinical QA and compliance. Good understanding
of regulatory and compliance requirements and guidelines. Role model in quality
delivery, reliability and integrity.
Good understanding of Good Manufacturing Practices
Demonstrated ability to think strategically and to be able to outline and drive successful
implementation.
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Deep understanding of clinical pharmacology and clinical early development studies in
healthy volunteers and patients. Experience in later phase clinical development Phase 2b
and 3 would be an important advantage.
Strong communication skills on an individual and group level. Ability to clearly
formulate business needs, priorities and initiatives. Strong commitment to leadership and
business values
Self-starter, flexible, solution-focused, persistent and creative – demonstrated ability to
solve complex issues across scientific disciplines.
Excellent planning and organizational skills along with strong customer focus.