Mir Md

Accomplished, high-impact Global Quality Executive with over a decade of leadership establishing, scaling, and managing robust Quality Management Systems (QMS) across complex manufacturing environments. Deep expertise executing regulatory compliance and digital data integrity under FDA 21 CFR Part 111 (Dietary Supplements), 21 CFR Part 210/211 (cGMP), and 21 CFR Part 11 (Electronic Records). Proven track record managing global vendor networks, supplier qualification programs, and contract manufacturing organizations (CMO/CDMO) to ensure purity, safety, and exact label integrity.

Expert in leading cross-functional teams, orchestrating facility audits, accelerating CAPA resolutions, and driving operational excellence to eliminate process bottlenecks in the high-volume nutraceutical and supplement sector.

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.

Master of Business Administration - Strategic Management & HR - Rajshahi University

Bachelor of Arts - UITS University