Title – Clinical QA Specialist
Months- 12+ Months (potential extension)
Location- Cambridge, MA (hybrid)
Pay Range- $120 – 125/hr. on W2 without Benefits
Objectives:
- 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
Accountabilities: (Describe the primary duties and responsibilities of the job.
- Approximately 5 – 10 bulleted task statements should be identified).
- 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
- Participate in GCP health authority inspections, as required
- Mentor and provide support to Manager level CQA personnel, as needed
- May act as supervisor for temporary contractors
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. ]
- Any minimum requirements should be highlighted.)
- 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.
- 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 analyse complex data.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
