Associate Director, Clinical Quality Compliance

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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