Senior Director Of Quality (Biotech)

TL;DR

Senior Director of Quality (Biotech): Leading the strategic and operational quality function for sterile injectable manufacturing with an accent on cGMP compliance, regulatory inspections, and validation processes. Focus on mentoring teams, driving cross-functional quality initiatives, and ensuring operational excellence in cleanroom environments.

Location: Must be based in York, United States

Company

BioTechnique is a sterile injectable full-service CDMO providing comprehensive fill-finish and lyophilization services for liquid injectables.

What you will do

• Provide strategic leadership and independent QA oversight across all cGMP-regulated areas including manufacturing and warehouse operations.
• Lead and manage quality assurance, compliance, and validation activities to ensure alignment with FDA and EMA standards.
• Serve as Subject Matter Expert for internal and external audits, regulatory inspections, and client engagements.
• Mentor, coach, and train personnel at all levels while fostering a culture of quality and accountability.
• Drive corrective actions and preventive measures through CAPA and deviation management systems.
• Support Business Development and MSAT initiatives with quality strategy and technical input.

Requirements

• Must be based in or able to work in York, United States.
• Bachelor’s degree in life sciences, engineering, or related field; Advanced degree (MS, MBA) preferred.
• Minimum 15 years of experience in pharmaceutical quality assurance with a focus on aseptic and sterile manufacturing.
• At least 5 years of leadership experience managing teams and projects in complex matrixed organizations.
• Extensive knowledge of FDA, EMA, cGMP, and ISO regulatory frameworks.
• Proven track record in hosting regulatory inspections and client audits.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance with 100% of employee premiums paid by the company.
• 401(k) plan with company matching.
• Generous PTO, sick time, and paid holidays.
• Education assistance and professional development support.
• Pet insurance and various financial/fitness perks.