Associate Director, Clinical Program Quality

Job Summary

• 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.
  
  

location: Cambridge, Massachusetts

job type: Contract

salary: $160.00 - 168.92 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• 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 company 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 the company. Facilitate appropriate and timely inspection responses and follow-up actions
• Analyze, 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, company 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
  
  

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 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 analyze complex data
  
  

Licenses/Certifications

• GCP Quality Assurance registration/certification preferred
  
  

Travel Requirements

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
• Requires approximately 30% travel.
  
  

skills: Good Clinical Practice (GCP), Quality Assurance (QA), International Council for Harmonization (ICH)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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