Jobs and Careers

Senior Director of Quality

United Statesfull_timeVerifiedPosted 31 Jul 2026

About the role

BioTechnique 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. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique 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 BioTechnique, it’s about more than just a job—it’s about your career and your future.

Your Role

The Quality Director will serve as the strategic and operational leader of BioTechnique’s Quality function, overseeing all aspects of Quality Assurance, Quality Control, Compliance, and Validation. This role is responsible for ensuring that BioTechnique 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 BioTechnique’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