WHK Quality & Regulatory Manager

Description:

QUALITY & REGULATORY MANAGER

Department: Quality Assurance / Regulatory Affairs
Location: Clearwater, Florida
Company: WHK BioSystems, LLC
Status: Full-Time (On Site)
Salary Range: $120,000+

POSITION SUMMARY

WHK BioSystems is seeking an experienced Quality & Regulatory Manager to lead, maintain, and continuously improve the company's Quality Management System while supporting the organization's growth within the medical device, life science, biopharmaceutical, and cell & gene therapy markets.

The Quality & Regulatory Manager is responsible for ensuring compliance with ISO 13485, FDA requirements, customer specifications, and internal quality standards. This individual will serve as the company's primary quality leader and will oversee quality assurance, regulatory compliance, supplier quality, audit management, risk management, validation support, and continuous improvement initiatives.

As WHK continues to expand its capabilities and customer base, this position will play a critical role in strengthening quality systems, enhancing cleanroom quality programs, supporting contamination control initiatives, developing environmental monitoring and bioburden programs, and assisting with future sterility assurance activities as customer requirements evolve.

The ideal candidate is a hands-on leader who is comfortable working directly with production personnel, engineers, customers, suppliers, auditors, consultants, and executive management.

COMPANY OVERVIEW

WHK BioSystems is an ISO 13485-certified and FDA-registered contract manufacturer serving the medical device, biopharmaceutical, life science, and cell & gene therapy industries.

WHK specializes in custom single-use assemblies, molded and overmolded components, tubing assemblies, cleanroom device assembly, and contract manufacturing solutions for highly regulated markets.

Operations include ISO Class 7 cleanroom manufacturing, injection molding, overmolding, tubing assembly, RF welding, laser processing, assembly, packaging, machining, and related manufacturing processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Management System Leadership

• Maintain and continuously improve WHK's ISO 13485 Quality Management System.
• Ensure compliance with ISO 13485, FDA regulations, customer requirements, and internal procedures.
• Manage document control systems, training systems, quality records, and quality documentation.
• Lead Management Review activities and quality performance reporting.
• Establish and monitor quality objectives and key performance indicators.
• Identify opportunities for continuous improvement and implement sustainable solutions.
• Ensure the organization remains audit-ready at all times.

Audit & Regulatory Compliance

• Lead internal audits, supplier audits, customer audits, and ISO certification audits.
• Serve as the primary company representative during external audits and inspections.
• Manage responses to audit findings and ensure timely closure of corrective actions.
• Support FDA inspection readiness and regulatory compliance initiatives.
• Coordinate customer quality surveys, supplier questionnaires, and regulatory documentation requests.
• Monitor and communicate changes in applicable quality and regulatory requirements.

CAPA, Nonconformance & Investigation Management

• Manage Corrective and Preventive Action (CAPA) programs.
• Lead root cause investigations utilizing appropriate quality methodologies and tools.
• Oversee nonconforming material investigations and disposition activities.
• Manage customer complaints and internal quality investigations.
• Monitor quality trends and implement corrective actions to prevent recurrence.
• Verify effectiveness of corrective actions and ensure timely closure.

Manufacturing Quality Support

• Support production operations involving cleanroom assembly, injection molding, overmolding, tubing assemblies, packaging, and related manufacturing processes.
• Review and approve inspection methods, acceptance criteria, quality plans, and production documentation.
• Participate in new product introductions, process changes, tooling changes, and customer-driven change controls.
• Support process validation and manufacturing qualification activities.
• Collaborate with Engineering and Operations to improve product quality and manufacturing performance.
• Promote a proactive quality culture focused on prevention and continuous improvement.

Cleanroom, Microbiology & Contamination Control

• Support and oversee quality activities associated with WHK's ISO Class 7 cleanroom operations.
• Maintain and improve contamination control programs and cleanroom quality systems.
• Support environmental monitoring programs, including viable and non-viable particulate monitoring.
• Assist with development and implementation of bioburden testing programs.
• Support cleanroom certification, recertification, and validation activities.
• Participate in investigations involving environmental excursions or contamination events.
• Support customer cleanliness and contamination control requirements.
• Assist with future sterility assurance initiatives as customer requirements evolve.
• Ensure appropriate gowning practices, personnel training, material flow, and cleanroom procedures are maintained.
• Coordinate with outside laboratories, consultants, and customers regarding microbiological testing and environmental monitoring requirements.

Supplier Quality Management

• Manage supplier qualification and supplier monitoring activities.
• Support supplier audits and supplier corrective action programs.
• Review supplier quality documentation, certificates of analysis, certificates of conformance, and related quality records.
• Partner with Purchasing and Engineering to resolve supplier quality issues.
• Maintain approved supplier records and supplier performance metrics.

Validation, Risk Management & Change Control

• Support process validation activities including IQ/OQ/PQ protocols and reports.
• Participate in risk assessments, PFMEAs, control plans, and process risk evaluations.
• Manage quality review of material, process, equipment, supplier, and document changes.
• Ensure changes are properly evaluated, documented, approved, and communicated.
• Support customer-required validation and qualification projects.

Team Leadership & Development

• Lead, mentor, and develop quality personnel including quality engineers, quality technicians, inspectors, and document control personnel.
• Establish departmental priorities and performance expectations.
• Support employee training and development initiatives.
• Foster a culture of accountability, teamwork, continuous improvement, and customer focus.
• Work collaboratively across all departments to achieve organizational objectives.

BENEFITS

• Competitive salary range of $120,000 - $150,000.
• Health, dental, and vision insurance.
• Paid time off and company holidays.
• Retirement savings plan.
• Professional development and training opportunities.
• Opportunity to lead quality and regulatory initiatives for a rapidly growing medical and biopharmaceutical contract manufacturer.

WHK BioSystems is an Equal Opportunity Employer and considers qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected classification.

REQUIRED QUALIFICATIONS

• Bachelor's degree in Engineering, Manufacturing, Quality, Life Sciences, Biology, Microbiology, Biomedical Engineering, or a related technical discipline.
• Minimum 7 years of progressive quality experience in a regulated manufacturing environment required.
• Minimum 10 years of quality experience strongly preferred.
• Minimum 3 years of leadership or supervisory experience.
• Strong working knowledge of ISO 13485 and quality management systems.
• Experience supporting FDA-regulated manufacturing operations.
• Experience managing CAPA systems, audit programs, nonconformances, supplier quality programs, and quality investigations.
• Demonstrated experience serving as a primary quality representative during customer audits, certification audits, and regulatory inspections.
• Strong understanding of root cause analysis methodologies and continuous improvement principles.
• Excellent communication, organizational, leadership, and project management skills.
• Ability to effectively interact with customers, auditors, suppliers, regulatory bodies, and executive leadership.
• Strong problem-solving, decision-making, and risk-management capabilities.

PREFERRED QUALIFICATIONS

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma, or equivalent certifications.
• Experience within medical device, biopharmaceutical, pharmaceutical, cell & gene therapy, or contract manufacturing environments.
• Experience supporting ISO Class 7 or ISO Class 8 cleanroom operations.
• Experience with environmental monitoring programs.
• Experience with bioburden testing programs.
• Knowledge of sterility assurance principles.
• Experience with contamination control programs.
• Experience with process validation and equipment qualification.
• Experience with supplier quality management in regulated industries.
• Experience supporting customer audits and regulatory inspections.

DESIRED ATTRIBUTES

• Hands-on leadership style.
• Strong business and manufacturing judgment.
• Ability to balance compliance requirements with operational realities.
• Comfortable working in a fast-paced growth environment.
• Highly organized and detail-oriented.
• Customer-focused mindset.
• Continuous improvement mentality.
• Strong interpersonal and team-building skills.

TARGET CANDIDATE PROFILE

Ideal candidates may currently hold positions such as:

• Quality & Regulatory Manager
• Quality Manager
• Quality Assurance Manager
• Quality Systems Manager
• Senior Quality Engineer ready for advancement
• Preferred backgrounds include:
• Medical Device Manufacturing
• Biopharmaceutical Manufacturing
• Cell & Gene Therapy Manufacturing
• Contract Manufacturing Organizations (CMO/CDMO)
• Single-Use Systems Manufacturing
• Cleanroom Manufacturing Operations

Candidates should be comfortable operating within an entrepreneurial manufacturing environment where they can directly influence quality systems, operational excellence, and company growth.

Compensation details: 120000 Yearly Salary

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