Senior Director of Quality

York, United States | Posted on 07/31/2026

Bio Technique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill‑finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill‑finish, and lyophilization services for a wide variety of liquid injectables. Bio Technique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi‑cultural team, Bio Technique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At Bio Technique, it’s about more than just a job—it’s about your career and your future.

The Quality Director will serve as the strategic and operational leader of Bio Technique’s Quality function, overseeing all aspects of Quality Assurance, Quality Control, Compliance, and Validation. This role is responsible for ensuring that Bio Technique maintains the highest standards of regulatory compliance, product quality, and operational excellence across sterile injectable manufacturing, lyophilization, and clinical logistics.

The Quality Director will lead internal QA/QC teams and manage external consultants, driving cross‑functional collaboration to resolve quality events, optimize validation processes, and support manufacturing operations in cleanroom environments. This individual will provide on‑the‑floor quality guidance, mentor junior staff, and ensure alignment with evolving regulatory expectations and sponsor requirements.

In addition to core quality responsibilities, the Quality Director will play a pivotal role in supporting Business Development (BD) initiatives, Manufacturing Science and Technology (MSAT) projects, and internal product approvals. The role includes project management responsibilities for selected customer programs and strategic input into sponsor engagement and innovation adoption.

• Provide strategic leadership and independent QA oversight across all cGMP-regulated areas, including:
• Critical utilities (WFI, Steam, Automation, HVAC, equipment)
• Warehouse operations
• Manufacturing processes
• Inspection, labeling, and packaging
• Batch record review and disposition
• New product introduction and product transfer
• External laboratories and supplier quality
• Lead and manage Bio Technique’s quality assurance, compliance, and validation activities, ensuring alignment with FDA, EMA, and international regulatory standards
• Execute tactical QA operations while overseeing and mentoring junior staff in real-time floor assessments, issue identification, documentation, and resolution
• Perform independent technical review of documentation during and post‑execution of cGMP activities, ensuring specifications and requirements are met
• Provide guidance and training across GMP areas (Manufacturing, QC, Validation) to ensure regulatory compliance and continuous improvement
• Sign off, qualify, and train junior staff on QA/QC/Validation responsibilities and ensure readiness for regulatory inspections
• Analyze findings and report to relevant departments; drive corrective actions and preventive measures through CAPA and deviation management systems
• Serve as Subject Matter Expert (SME) for internal and external audits, regulatory inspections, and client engagements; lead inspection readiness activities
• Maintain the approved supplier list and oversee external vendor compliance and investigations
• Lead validation projects and ensure systems, processes, and documentation meet regulatory and internal standards
• Provide quality oversight for change management…