Summary
Overview
Work History
Education
Skills
Timeline
Generic

MICHAEL STOCKS, MS

Chapin,SC

Summary

Strategic and results-driven senior quality leader with extensive experience in pharmaceuticals, medical devices, OTC drugs, dietary supplements, and cosmetics. Expertise in regulatory compliance, quality systems, and operational excellence facilitates the development and leadership of high-performing teams while driving cultural transformation. Proven ability to navigate complex regulatory landscapes and mitigate risks ensures market access and sustained compliance. A collaborative and pragmatic approach fosters a culture of accountability and continuous improvement within organizations.

Overview

13
13
years of professional experience

Work History

Head of Regulatory Affairs

Northern Digital Inc.
12.2023 - Current
  • Spearheaded global regulatory compliance and quality assurance for sterile medical devices and related components, leading the site's regulatory affairs function. Orchestrated the worldwide market introduction of two new devices by developing and executing strategic regulatory plans aligned with key global regulations, including the EU's 2017/745 MDR and China's NMPA. Championed the implementation of an electronic quality management system (eQMS) and established new regulatory performance indicators (KPIs), fostering a culture of compliance. Served as the primary liaison with international regulatory authorities, ensuring adherence throughout the product lifecycle.

Director of Quality

Autumn Harp
11.2020 - 10.2023
  • Engineered and executed global quality strategies, introducing key performance indicators (KPIs) that directly improved performance across all product lines, including FDA-regulated OTC drug products and cosmetics. Established a robust quality organization and cultivated a company-wide quality culture. Directed the selection and implementation of a new eQMS that successfully met compliance requirements and supported the organization’s pharmaceutical customers.

Senior Director of Quality

Edge Pharma
10.2018 - 10.2020
  • Provided strategic leadership for the quality organization by developing and implementing comprehensive quality assurance programs tailored to both sterile and non-sterile 503B compounding pharmacy operations. Led the development and execution of quality systems and policies that ensured full compliance with FDA, USP, and cGMP regulations. Directed quality oversight activities including internal audits, deviation investigations, risk assessments, and regulatory inspections, successfully resolving multiple open FDA observations to maintain compliance. Built and mentored a reliable quality assurance team, fostering a strong quality culture and cross-functional collaboration to support continuous improvement. Managed final drug product release, ensuring all quality criteria were met before market distribution. Maintained strong relationships with regulatory bodies to ensure ongoing compliance and inspection readiness, driving high standards of product safety and efficacy.

Vice President of Quality

New Chapter
04.2016 - 03.2018
  • Provided strategic leadership for the quality organization by developing and implementing a holistic quality vision, strategies, and policies that aligned with corporate growth objectives and regulatory requirements. Directed the successful launch of eight new dietary supplement products, ensuring full compliance from development through market release. Fostered a strong quality culture and enhanced employee competencies across the company. Maintained positive relationships with the FDA, NSF, and other regulatory bodies.

Quality Assurance Director

Seldon
02.2013 - 09.2016
  • Oversaw all quality-related activities at the facility and provided strong leadership to ensure ongoing compliance and foster a quality-driven culture at all organizational levels. Collaborated with cross-functional management to streamline business and manufacturing processes, which enhanced product reliability, reduced costs, and minimized quality-related risks. Directed all quality and regulatory activities, including managing regulatory approvals, environmental management, sustainability, and ensuring product quality standards were met.

Education

MS - Health Services Administration

Sage Graduate School
Troy, NY

BA - English/Economics

College of Wooster
Wooster, OH

MS - Pharmaceutical Manufacturing

Stevens Institute
Hoboken, NJ

Skills

  • Quality & Regulatory Leadership: Expert in global regulatory frameworks, including FDA, EU MDR, UKCA, ISO standards (9001, 13485, 14971), and cGMP regulations
  • Operational Excellence: Skilled in Lean Manufacturing, process optimization, financial management, and operational budgeting
  • Team & Culture Development: Adept at fostering trust, accountability, and excellence to build quality-centric and business-driven organizations
  • Project & Risk Management: Proficient in strategic planning, project management, and risk mitigation to ensure successful product development and market entry

Timeline

Head of Regulatory Affairs

Northern Digital Inc.
12.2023 - Current

Director of Quality

Autumn Harp
11.2020 - 10.2023

Senior Director of Quality

Edge Pharma
10.2018 - 10.2020

Vice President of Quality

New Chapter
04.2016 - 03.2018

Quality Assurance Director

Seldon
02.2013 - 09.2016

BA - English/Economics

College of Wooster

MS - Pharmaceutical Manufacturing

Stevens Institute

MS - Health Services Administration

Sage Graduate School

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MICHAEL STOCKS, MS