QA Associate Director CMC Regulatory Submission QC and Audit

The QA Associate Director CMC Regulatory Submission QC and Audit is responsible for the audit/review of all regulatory submissions in support of submission readiness for small molecule biologics and medical devices. This position will be responsible for auditing/reviewing regulatory submissions working closely with the Regulatory Affairs Quality Assurance Operational QA and business stakeholders to ensure the quality and ontime delivery of our regulatory submissions to support global expansion efforts scaleup and post approval changes. This role will manage and maintain submission audits ensuring that plans are in place and that activities are completed to support submission timing and expectations. It is also responsible for the development and maintenance of GMP Certificates and Declarations and other compliance documentation for submissions.

Key Duties and Responsibilities:

• Engages with relevant stakeholders to develop a holistic Quality strategy for regulatory submission audits

• Serves as process owner and provides oversight of the submission audits (IND/NDA and international equivalents) and supports global expansion efforts scaleup and post approval changes

• Ensures robustness of submission audit process including implementation of improvements and establishment of metrics

• Develops maintains and executes strategic Audit Plans to support Regulatory Submission audits (GMP/GDP/ Biologics/ Medical Devices)

• Partners with key stakeholders for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement

• Compare source data e.g. certificates of analysis batch records comparative analysis reports stability reports etc. with submission data

• Represent QA and Compliance at all submission related kickoff meetings & raise any risks & provide any necessary direction

• Attend submission review meetings to support filings responses to health authority filing inquiries and review submission content for accuracy

• Support all compliance document requirements for submissions e.g. Certificates Declarations Powers of Attorney and other local legally required documents)

• Participates in collaborative review of impacted SOPs/WIs

• Escalates critical and major findings/issues to Quality management

• Develops reviews and analyzes Key Performance Indicator data and trends related to regulatory submissions audits for GMP/GDP/ Biologics/ Medical Devices

• Drive process improvement initiatives related to regulatory submission data integrity audits

• May engage in preparation support and followup activities for regulatory inspections

• Support other activities projects etc. related to the Inspection Readiness team as necessary

Knowledge and Skills:

• QA audit experience / data review and verification

• Indepth knowledge in the following areas:

• Regulatory Submission requirements (INDs//NDAs/SNDAs and international equivalents)

• Regulatory Submission Data Review

• GMP/GDP/ Biologics/ Medical Devices Audit processes

• GMP/GDP/ Biologics/ Medical Devices Quality Systems

• Global GMP regulations (US/EU etc.; 21 CFR Part 210/211 ICH guidelines and international equivalents as necessary

• Global Biologics regulations (US/ EU etc.; 21CFR Part 600/ 680 ICH guidelines and international equivalents as necessary

• Global Medical Device regulations (US/ EU etc.; 21CFR Part 810/ 820 ISO 13485 ICH guidelines and international equivalents as necessary

• CMC Documentation (e.g. NDA Submissions.

• Project management experience

• Ability to work autonomously with minimal oversight and with urgency to support filing timelines

• Experience and ability to participate on crossfunctional teams be extremely collaborative and flexible

• Excellent communication skills and a proven track record influencing/ building/ promoting a culture of continuous improvement

• General global experience in life sciences Quality Operations and Regulatory

Education and Experience:

• M.S. (or equivalent degree) and 58 years of relevant work experience or B.S. in a scientific or allied health field and 10 years of relevant work experience or relevant comparable background

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