Sr Program Manager, Clinical Compound Support Quality Assurance

At Proclinical, we are seeking an individual to fill the role of Program Manager, Clinical Compound Support Quality Assurance, based in Cambridge, MA.

Responsibilities

• Manage Therapeutic Area Programs of a highly complex nature and/or high-risk programs.
• Provide GCP QA leadership to drug development teams.
• Act as a quality expert to provide GCP compliance interpretation, consultation, training, and recommendations.
• Coach, educate and collaborate with external sites and cross functional staff in global regulatory readiness activities and responses in support of successful marketing applications.
• Lead domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH and policies and procedures. Assess impact of audit findings on relevant subjects.
• Audits conducted require advanced auditing skills and may include the technically complex assignments, including audits of potentially high-risk studies/vendors.
• Collaborate with all related functional areas to ensure that clinical trial activities are conducted in compliance with internal and external guidelines and requirements.
• Develop and implement a strategic quality plan for assigned compounds.
• Supervise and manage investigations into scientific misconducts and/or serious breach of GCP.
• Assure reporting of potential or confirmed violations to regulatory authorities.
• Assist R&D during GCP regulatory inspections.
• Provide GCP compliance technical support during inspections of investigator sites and facilities.
• Identify and mitigate GCP quality and compliance issues.
• Monitor and analyze compliance issues identified across clinical programs.
• Report metrics for assigned compounds to QA management, clinical staff.
• Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.

Skills And Qualifications

• BS in related field and 7+ years of relevant experience.
• ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional - GCP certification preferred, but not required.
• 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.
• Strong written, verbal, and interpersonal communication skills.
• Requires approximately 30% travel.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Christopher Frank at (+1) 2674056996 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.