WHK Quality & Regulatory Manager

Quality & Regulatory Manager

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.

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 include:

• Quality Management System Leadership
• Audit & Regulatory Compliance
• CAPA, Nonconformance & Investigation Management
• Manufacturing Quality Support
• Cleanroom, Microbiology & Contamination Control
• Supplier Quality Management
• Validation, Risk Management & Change Control
• Team Leadership & Development

Benefits include:

• 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 include:

• 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 include:

• 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 include:

• 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 includes:

• 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.