Program Manager, R&D Quality Assurance, GCP - MA

• Full-time

This is a 50/50 split

Honor period: 3 months

• minimum: $110,000
• Maximum: $130,000
• target:$na
• Bonus: 13%
• Travel: 25%
• Sponsor/transfer H-13 and/or H-2B:
  No
• sponsor / transfer work permits: no
• Paid relocation: yes
• industry:
  Biotechnology/Pharmaceuticals

The purpose of this position is to ensure that clinical trial activities for all assigned projects are conducted in compliance with applicable regulations, Good Clinical Practice (GCP) guidelines, the International Conference on Harmonization (ICH) and Policies and Procedures. In addition, this position is responsible for ensuring that investigator sites, external vendors and internal processes meet quality standards. The position’s incumbent is responsible for technically complex assignments, accurately identifying and communicating compliance risks, and developing action plans to mitigate risks.

• Responsible for collaborating with Global Compound Support Quality Assurance function to develop and implement a strategic audit plan for the development of all assigned US compounds. Ensure that activities are conducted and reports written according to applicable regulations and SOPs.
• Lead domestic and international audits of clinical investigator sites, documents, databases, vendors (clinical, bioanalytical, and GLP), and internal systems to assure compliance with the Code of Federal Regulations, local regulations, ICH and policies and procedures. Audits conducted will require advanced auditing skills and will include the most technically complex assignments, including audits of potentially high risk. Assess impact of audit findings on subject safety, data integrity, and business operations.
• Obtain audit responses from functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and policies. Facilitate risk remediation. Escalate inadequate audit response to senior CQA management.
• Lead investigations into scientific misconduct and/or serious breach of GCP. Analyze investigation findings to identify root/probable cause. Propose, document, and track appropriate corrective actions. Assure reporting of potential or confirmed violations, as appropriate, to regulatory agencies. As assigned, review and approve audit reports submitted by Clinical Compound Support Compliance Specialists for content, format, regulatory risks, and compliance with SOPs. Promote consistent audit report writing standards across function.
• Participate in the development and implementation of a comprehensive training program for Clinical Compound Support Quality Assurance. As appropriate, monitor and document Compliance Specialist / Associate Compliance Specialist progress against the training program.
• Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.
• Manage audit teams, including outside contractor auditors, to assure compliance with objectives of this position.
• Report metrics associated with assigned compounds to QA management, clinical development clinical development staff, and contract research organization staff. Evaluate if corrective and/or preventative actions are required, and ensure implementation.
• Identify potential systemic compliance risks, through audit activities and data analysis, and elevate to immediate manager for immediate and long-term resolution.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely product applications to worldwide regulatory authorities. Independently analyze and interpret regulatory…