Job Title: Associate Director, Clinical Program Quality
Location: Cambridge MA
Duration: 12 Months
 
OBJECTIVES:

•  Provides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
•  Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
•  With the guidance of Head of Clinical Program Quality, TAU, defines and implements a risk-based program audit strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate and timely investigations and mitigations are in place.
•  Leads the clinical pre-approval inspection (PAI) readiness programs, the management of the inspection and the response and follow-up activities. Ensures that any inspection risks are well-communicated and mitigated. These inspections include both sponsor and investigator sites.

 
ACCOUNTABILITIES:

•  Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
•  Assume complex assignments on issues or studies where there is no precedent
•  Mentor and provide support to Manager level CPQ personnel, as needed
•  Represent CPQ in program-specific meetings and global CPQ team assigned
•  Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical study delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and 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 CPMQ management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
•  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.
•  Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions
•  Analyse, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
•  Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.
•  Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
•  Participate in due diligence activities and process improvement initiatives as requested by management
•  May act as supervisor for temporary contractors

 
 
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

•  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 or relevant clinical trial experience.
•  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, comfortable with stakeholder management, with a positive attitude, critical thinking skills and the 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 analyse complex data

 
LICENSES/CERTIFICATIONS:
GCP Quality Assurance registration/certification preferred
 
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
 Routine demands of an office-based environment
 
TRAVEL REQUIREMENTS:
 Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
 Requires approximately 30% travel.
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 150.00/hr.