Director of Quality Assurance - Double Wood Supplements - Greater Philadelphia Area (Hybrid)
(2023-02)
- Strategic Supplement Governance: Direct global Quality Operations for a prominent dietary supplement and product-line portfolio, ensuring strict adherence to FDA 21 CFR Part 111 and Part 210/211 cGMP frameworks.
- Testing & Label Integrity: Oversee complex material review protocols, heavy metal/microbial contamination analysis, and third-party validation matrices to issue consumer-facing Certificates of Analysis (COAs).
- Audit Leadership & Vendor Risk: Manage comprehensive internal, external, and third-party supplier audits, standardizing global vendor qualification metrics across international raw material providers and ingredient suppliers.
- QMS Implementation: Architect corporate QMS infrastructure, automating systemic document lifecycles, analytical identity-testing protocols, and data trace frameworks under strict digital regulations.
- Process Optimization: Streamlined site CAPA systems and manufacturing deviation management protocols, reducing corporate regulatory cycle times and process bottlenecks by 20%.
Head of Quality, North America - Orifarm - United States (Hybrid)
(2021-10 - 2022-10)
- GxP & Supplement Governance: Maintained regional GxP Quality Management Systems governing North American operations, applying strict quality baseline validations adaptable to premium ingredient sourcing.
- Risk & Ingredient Remediation: Directed proactive CAPA initiatives and material review protocols to ensure operations, supply lines, and formulations aligned completely with FDA and international health regulations.
- Vendor Risk Assessment: Designed a preventative vendor risk-assessment framework, dramatically securing the integrity of the complex ingredient supply and distribution pipeline.
Quality Management Specialist - Merck - North Wales, PA
(2021-01 - 2021-10)
- Compliance & Batch Integrity: Managed daily compliance activities, cross-functional batch record reviews, and material deviation logs under strict FDA regulations to guarantee absolute formula safety and compliance.
- Deviation Investigation: Led root-cause analysis investigations for production anomalies, deploying long-term corrective and preventive actions (CAPA) to avoid recurrence.
Quality Assurance Manager - Eurofins - Greater Philadelphia Area
(2019-07 - 2020-12)
- Laboratory QMS & Testing: Spearheaded the end-to-end implementation of corporate QMS architectures across high-throughput laboratory and clinical/analytical testing sites evaluating product purity.
- Data Reliability & Part 11: Maintained rigorous research testing standards, ensuring absolute data integrity and data trace verification under 21 CFR Part 11 electronic records frameworks.
- Process Stability: Directed local CAPA programs, leveraging analytical tools to quickly isolate root causes of operational deviations and secure absolute process stability.
Quality Management System Specialist - Johnson & Johnson (McNeil Consumer & Specialty Pharmaceuticals) - Fort Washington, PA
(2018-08 - 2019-07)
- OTC & Formulation Support: Provided quality systems support for over-the-counter (OTC) consumer wellness and manufacturing workflows under strict cGMP guidelines.
- System Auditing: Conducted regular site-level QMS architecture audits to ensure absolute alignment with corporate quality guidelines, safety benchmarks, and FDA rules.
- Remediation Facilitation: Partnered with manufacturing teams to facilitate rapid investigation and remediation of high-stakes compliance issues.
Quality Assurance Specialist - Martech Medical Products, Inc. - Harleysville, PA
(2017-01 - 2018-08)
- Standards & Compliance Execution: Applied rigorous ISO and quality benchmarks to preserve manufacturing line compliance, maintaining strict alignment with FDA regulations through SOP and quality assurance plan (QAP) execution.
- Cross-Functional Workflows: Supported cross-functional teams in maintaining rigorous compliance workflows across cGMP and GLP operational spaces.
Quality Assurance Specialist - Airtel - Rajshahi, Bangladesh
(2013-01 - 2016-06)
- Regional Logistics Quality: Directed high-volume operations across the Quality and divisional logistics departments, engineering risk management strategies to secure operational continuity and material control.
- Document Control & Risk Mitigation: Developed comprehensive risk strategies and oversaw high-volume document control workflows to guarantee compliance with internal audits and corporate standards.
