Director, Quality Operations

BioTissue Holdings Inc; Miami (FL); On-site; USD 156,000 - 195,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off

Job summary

BioTissue Holdings Inc. in Miami, FL, seeks a Director of Quality Operations to lead the site quality-operations across manufacturing, packaging, and distribution. You will ensure GMP/GTP/ISO compliance and drive continuous improvement in the Quality Management System.

The role requires strategic leadership, budget management, and cross-functional collaboration with Operations, R&D and Supply Chain to ensure product quality and patient safety. Strong regulatory acumen is essential for success.

Qualifications

• Bachelor's Degree in Life Sciences or related field required.
• Master's Degree in Life Sciences, QA/Regulatory Affairs, MBA or related field preferred.
• AATB CTBS, CQE, CQA certifications preferred.
• Minimum 15 years of experience in FDA-regulated industry required.
• Minimum 5 years QA and people management experience required.

Responsibilities

• Lead and direct site quality-operations across manufacturing, packaging, labeling and distribution.
• Ensure compliant product disposition and release under GMP, GTP, ISO and other regs.
• Drive QMS improvements via Change Control, CAPA, Risk Management and Audit programs.
• Collaborate with Operations to align quality strategies with manufacturing goals.
• Monitor quality performance metrics and report to site leadership and QMR.
• Manage budget, resources and personnel development within the Quality dept.

Skills

Quality leadership

Regulatory compliance

GxP ISO knowledge

Budget management

Cross-functional leadership

Education

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences/QA-RA/MBA

AATB CTBS

ASQ CQE

CQA

Tools

eQMS

ERP systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Director, Quality Operations

Full Time Sr.Mgmt: Dir&Up Miami, FL, US

5 days ago Requisition ID: 1706

Salary Range: $156,079.00 To $195,098.00 Annually

About BioTissue & our Culture

At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going.

Position Summary

Responsible for leading the Quality Operations Team across the company’s manufacturing site, ensuring compliance with GTP, GMP, ISO, and other applicable regulatory requirements while supporting product quality, patient safety, and operational excellence. This includes oversight of site-based quality operations, including raw material inspection and release, finished product lot release activities, quality engineering and supporting the site quality management system

Provides strategic leadership to ensure quality systems, processes, and procedures are effectively implemented, maintained, and continuously improved in accordance with regulatory expectations and industry best practices. Serves as the site subject matter expert for GTP/GMP/ISO compliance, partnering with cross-functional teams to drive quality performance, mitigate risk, support manufacturing operations, and maintain a state of inspection readiness.

This role is responsible for departmental budgets, resource allocation, and daily quality operations while fostering a culture of accountability, problem-solving, professional development, and continuous improvement.

• Lead and develop all aspects of site quality-operations, including manufacturing, packaging, labelling, distribution, quality engineering ensuring consistent execution of quality standards and alignment with organizational objectives.
• Ensure compliant product disposition and release in accordance with GMP, GTP, ISO and other applicable regulations.
• Champion the application of GxP, ISO, and AATB quality principles to drive product and process improvements through effective utilization of Quality Management System elements, including Change Control, Nonconformance Management, Quality Engineering, CAPA, Risk Management, and Audit programs.
• Serve as a key leader in advancing a strong quality culture across the organization, influencing both internal and external stakeholders while driving continuous improvement of the site Quality Management System.
• Establish priorities, allocate resources, and manage team workloads to support manufacturing and supply chain objectives while monitoring performance metrics and ensuring achievement of departmental goals.
• Partner closely with Operations leadership to align quality strategies, business priorities, and operational objectives, enabling efficient and compliant execution of manufacturing activities.
• Act as the site Quality subject matter expert, maintaining deep knowledge of quality systems, standard operating procedures, work instructions, and regulatory requirements, while ensuring effective integration and execution of all quality processes.
• Review and approve standard operating procedures, work instructions, validation protocols, qualification reports, and other quality documentation to ensure compliance, accuracy, and operational effectiveness.
• Collaborate with Technical Operations, Supply Chain, Production, and Research & Development teams to successfully transfer new products, technologies, and process improvements into commercial manufacturing environments.
• Lead the monitoring, analysis, and reporting of site quality performance metrics, identifying trends, risks, and improvement opportunities while providing clear visibility to site leadership and the Quality Management Representative (QMR).
• Ensure the effective management of the Quality department through talent development, succession planning, employee engagement, budget administration, cost control, workplace safety, coaching, and performance management.
• Promote and maintain a robust continuing education program that strengthens organizational knowledge of regulatory requirements, industry best practices, and quality expectations within a regulated manufacturing environment.

Skills & Abilities

Essential Duty Definition:

• Ability to make informed decisions, think critically and strategically, solve problems, and respond proactively; must have excellent communication skills (both written and oral); strong time-management skills required.
• The role requires strong and visible leadership presence with accountability for setting direction, driving execution, and fostering a culture of ownership, collaboration, and continuous improvement.
• The incumbent must demonstrate the ability to lead cross-functional teams, influence stakeholders at multiple levels, make timely and sound decisions, and develop talent through coaching, feedback, and clear performance expectations.
• This role must emphasize not only technical competence, but also the ability to inspire confidence, manage change effectively, resolve issues with urgency, and uphold high standards of quality, compliance, and business performance.
• Computer Proficiency – Word, Excel and Access, Electronic Quality Management Systems.

Position Expertise/Qualifications

• Bachelor's Degree in Life Sciences or a related field, required
• Master's Degree in Life Sciences, Quality Assurance/Regulatory Affairs (QA/RA), MBA, or a related field, preferred
• American Association of Tissue Banks (AATB) Certified Tissue Banking Specialist (CTBS), preferred
• American Society for Quality (ASQ) Certified Quality Engineer (CQE), preferred
• Certified Quality Auditor (CQA), preferred
• Minimum 15 years of experience in an FDA-regulated industry, required
• Minimum 5 years of Quality Assurance and people management experience, required
• Minimum 5 years of experience utilizing an electronic Quality Management System (eQMS), required
• Minimum 2 years of experience working with Enterprise Resource Planning (ERP) systems, preferred

Physical Requirements

• Sedentary work that generally requires sitting and/or standing

Total Rewards

At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.

Our benefits may include:

• Medical, Dental, and Vision Insurance
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
• 401(k) Retirement Savings Plan
• Company-Paid Basic Life and AD&D Insurance
• Voluntary Life and AD&D Insurance
• Short-Term and Long-Term Disability Coverage
• Employee Assistance Program (EAP)
• Legal and Identity Protection Benefits
• Pet Insurance
• Paid Time Off and Company Holidays
• Paid Parental and Birthing Leave
• Family and Medical Leave (FMLA), where applicable
• Tuition Reimbursement and Professional Development Support
• Performance-Based Incentive Opportunities
• Equity or Stock Programs, where applicable

Benefits eligibility and offerings may vary based on position, location, and employment status.

ADA Statement

BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.

Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.

BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.