• Managed product release process (including API, DS, and DP) of biologics.• Reviewed and approved Certificates of Analysis and Certificates of Complaince for API, DS, and DP.• Provided guidance during internal investigations for CAPAs, events, and other non-conformities.• Performed supplier audits (CMO, domestic and international).• Managed QA team of five, successfully improving their performance in the midst of rapidly changing requirements.• Reviewed and approved labeling for clinical studies.• Represented Quality function in all drug development programs.• Provided input to program teams on ICH guidelines.• Reviewed regulatory filings for microbiome therapeutics, focused on CMC sections.

• Managed MDSAP recertification audit resulting in 0 nonconformities.• Managed the CAPA system, including working with various stakeholders to resolve stagnant CAPAs.• Implemented streamlined training program that reduced training burden by 20%.• Developed plan to improve and streamline eQMS workflows to serve multiple sites and multiple business units.

• Developed and implemented a Quality System roadmap compliant with 21 CFR 211 and 820.• Led development of an Agile based Software Development Process compliant with 21 CFR 820.30 and IEC 62304.• Led cross-functional team on selection and implementation of an eQMS solution.• Managed supplier and vendor quality, negotiated Quality Agreements, and conducted audits to 21 CFR 58 and 211.• Provided input to Regulatory for submission of pre-Subs, IDEs, and Annual Reports. • Performed drug substance and drug product batch reviews

• Led team that transitioned from ISO 13485:2003 to ISO 13485:2016, leading to a zero-nonconformity assessment audit.• Key member of team that transitioned from a paper based QMS to an electronic QMS.• Led Quality aspects for the planning and implementation of a fully automated production facility.• Delivered interactive Design Control training sessions.• Developed Quality staffing plan for new production facility.• Represented Quality interests in determining optimum layout of new production facility.• Led team to create and execute Master Validation Plan for new $200 MM production facility, including 70,000 sq ft ISO Class 8 cleanroom and $60 MM automated production equipment.• Performed supplier audits to assist supplier quality group.

• Implemented a two-year Operations Master Planning process driving continuous improvement initiatives. • Managed several FDA audits resulting in zero findings.• Managed staff of 5.• Managed Quality budget.• Implemented IEC 62304 compliant software development process.• Led effort to design, validate, and deploy Part 11 compliant Complaint Management System.• Transitioned company from paper to Part 11 compliant eQMS.• Implemented overhaul of Supplier Management system, and led global Quality strategy.• Responsible for Quality in three (3) manufacturing sites.• Led the registrations and qualification of a new 40K sq./ft. biosensor manufacturing facility in Southern China.• Directed the development of Chinese FDA regulatory strategy for all products.• Implemented Continuous Improvement Process resulting in average field failure rates of < 300ppm.• Contributed to the implementation of Corporate Social Responsibility standard for China manufacturing sites.• Led effort to coordinate and align Management Reviews among all corporate sites (US, Hong Kong, China).• Member of Corporate Due Diligence team in acquisition of Hong Kong and China business.

• Assisted in scale-up of manufacturing operations.• Partnered with suppliers to resolve quality issues.• Led ETO sterilization batch release.• Performed vendor audits and complaint investigations.• Implemented quality systems to support initial commercial manufacturing.

• Overhauled QMS system to address FDA Warning Letter, leading to clearing of Warning Letter.• Implemented new Complaint Handling and Investigation system, leading to decreased complaint rate.• Reduced consumable failure rate from over 5% to less than ½%.• Assisted in producing 510(k) submissions.

• Led Quality Control activities, including product release testing.• Management Representative for ISO activities.• Performed system level failure analysis and led software and product validation efforts.