Head of Quality

Position Overview: This position will be responsible for planning, organizing, and overseeing the Quality strategy to ensure the timely delivery of safe and effective products that meet all regulatory and compliance requirements. This role will ensure that processes required for the Quality Management System(s) are effectively established, implemented, maintained, and will proactively develop improved processes to comply with the requirements of 21 CFR Parts 820 (Medical Devices) and 1271 (Human Cells, Tissues, and Cellular and Tissue). This person will also lead the Quality team and work closely with key partners, including Operations, R&D, and Regulatory to support the company in achieving its strategic goals through its current and future product platforms. This position will be located on-site in the company’s new Gaithersburg, MD facility.

Essential Duties & Responsibilities:

• Serve as the senior Quality leader within the company, and as a business leader.
• Understand company strategy, anticipate quality requirements, and implement changes or improvements to support business growth.
• Operationalize the company strategy within the Quality organization.
• Manage/oversee Quality Assurance responsibilities related to Operations, Quality Systems, and Quality Engineering activities.
• Lead the Quality organization, including building out the Quality team for the Gaithersburg, MD facility and leading the Quality team in Roswell, GA. Travel to the Roswell, GA facility as needed.
• Establish and implement the quality systems to comply with regulatory requirements, including FDA QSR (21 CFR 820 and 1271), ISO 13485, CMDCAS, etc. as applicable to business requirements.
• Establish capabilities as needed to ensure quality standards are met and compliance requirements are consistently achieved throughout the organization.
• Communicate the status of the quality system to senior leadership using established metrics and reports.
• Lead or participate in multidisciplinary teams for new product development and/or to resolve complex product investigations.
• Manage, interact, and engage with FDA, notified bodies, and international regulators during on-site audits/inspections, field actions, recalls, or post-market surveillance/vigilance activities.
• Engage with key external partners (e.g., vendors and consultants) on Quality priorities, process improvements, validations, etc.

Education & Experience:

• BS in a scientific discipline required.
• Minimum of 5 years of experience in a management role and extensive quality experience in an FDA and ISO regulated environment, with specific knowledge of 21 CFR Part(s) 820 and 1271.
• Significant experience in the healthcare industry (medical device, pharmaceutical) in both Commercial and R&D/Product development environments; experience with combination products (device/drug) a plus.
• Demonstrated capability in business process/system management and improvement.
• Experience running a Quality Control (QC) lab for analytical testing, environmental monitoring, etc. a plus.

Specialized Skills & Knowledge:

• Strong familiarity with Quality System (FDA and ISO 13485) requirements.
• Experience interfacing with government and accreditation agencies (FDA, ISO, AATB), managing audits, and supporting regulatory filings, responses, and other documents required in a regulated environment.
• Strong leadership skills: demonstrated ability to clearly develop, articulate, and achieve goals to drive performance and strategic growth.
• Ability to juggle multiple tasks and prioritize work appropriately with a focus on timelines and deliverables.
• Excellent judgment and decision-making capabilities; must be able to formulate business solutions to a myriad of challenges.
• Ability to work collaboratively with various internal departments and leaders.
• Ability to build out and lead a team of Quality professionals.
• Experience with analytical drug testing (HPLC, MS, GCMS, UV-Vis, NMR, etc.), interpreting results, and troubleshooting as needed.

Certification Requirements:

• None required, ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred.