Quality Director: Regulatory Compliance & Validation Leadership

PSC Biotech® Corporation; York (York County); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) and matching

PTO, Sick Time, Holidays

Education Assistance

Pet Insurance

Fitness perks

Discounts

Job summary

BioTechnique is seeking a Quality Director to lead the Quality function across QA, QC, Compliance, and Validation. You will ensure regulatory compliance and operational excellence in sterile injectable manufacturing, lyophilization, and clinical logistics.

This role also supports BD, MSAT projects, and sponsor engagements with on-the-floor guidance. You will mentor staff, drive continuous improvement, and manage internal/external QA resources to achieve strategic quality objectives and

Qualifications

• Minimum 15 years of experience in pharmaceutical quality assurance with aseptic and sterile manufacturing
• At least 5 years of leadership experience managing teams within complex matrixed organizations
• Extensive experience with FDA/EMA regulatory frameworks and regulatory inspections
• Strong independent judgment, decision-making, and project management skills

Responsibilities

• Provide strategic leadership across QA, QC, Compliance, and Validation
• Lead internal QA/QC teams and manage external consultants
• Drive CAPA, deviation management, and change controls to ensure regulatory compliance
• Oversee validation projects and supplier/vendor qualification activities
• Prepare for regulatory inspections and client audits, ensuring readiness

Skills

Leadership

Quality assurance

Regulatory compliance

cGMP experience

Audits & inspections

Cross-functional leadership

Education

Bachelor’s degree or higher

Advanced degree (MS, MBA, or equivalent)

Job description

BioTechnique is seeking a Quality Director to lead the Quality function across QA, QC, Compliance, and Validation. You will ensure regulatory compliance and operational excellence in sterile injectable manufacturing, lyophilization, and clinical logistics.

This role also supports BD, MSAT projects, and sponsor engagements with on-the-floor guidance. You will mentor staff, drive continuous improvement, and manage internal/external QA resources to achieve strategic quality objectives and