Sr. Director, Quality Control

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make
The Director of the GMP Quality Control (QC) Laboratory provides strategic, scientific, and operational leadership for the site's Chemistry, Microbiology, and Device laboratories as well as sterility assurance department in support of sterile injectable and combination product manufacturing. This role ensures compliance with global GMP regulations, corporate policies, and client requirements, while delivering accurate, timely, and reliable analytical results to support batch release and stability programs.

The Director will drive technical excellence, inspection readiness, and continuous improvement across all QC functions, fostering a culture of collaboration, accountability, and scientific integrity. This is a key leadership position within the site Quality organization and plays an integral role in regulatory interactions, client relationships, and cross-functional alignment

Essential Job Functions
Strategic & Operational Leadership

• Lead QC laboratory operations, ensuring alignment with site and corporate objectives, regulatory requirements, and customer expectations.
• Develop and execute a QC strategy supporting sterile fill-finish and combination product manufacturing, method lifecycle management, and capacity planning.
• Manage short- and long-term planning for operation, staffing, and budgets, including capital investments.

Regulatory Compliance & Inspection Readiness

• Ensure continuous compliance with GMP, compendial, and corporate requirements.
• Maintain inspection readiness for regulatory agencies (FDA, EMA, MHRA, etc.) and client audits; serve as the QC lead during inspections and laboratory tours.
• Ensure adherence to ALCOA+ data integrity principles and oversee robust laboratory documentation practices.

Technical & Scientific Oversight

• Provide scientific guidance for method transfer, qualification, and validation in compliance with ICH and industry best practices.
• Oversee analytical chemistry, microbiology, environmental monitoring, and combination product testing, ensuring timely and accurate results for product release and stability.
• Direct resolution of complex technical challenges and laboratory investigations, ensuring root cause analysis and effective CAPA implementation.

People Leadership & Development

• Lead, coach, and develop QC management and staff, fostering high technical standards, professional growth, and cross-training.
• Promote a culture of safety, teamwork, and continuous improvement.
• Ensure effective succession planning and talent development for critical QC roles.

Cross-Functional & Client Collaboration

• Serve as the QC technical liaison with clients, providing transparent updates and resolving testing or compliance concerns.
• Partner with Manufacturing, QA, Engineering, and Project Management to ensure coordinated support for product release, deviations, and technology transfers.
• Promote harmonization and best practice sharing across QC disciplines and other company laboratories.

Basic Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, or related life science;
• 10+ years of experience in pharmaceutical QC laboratories
• 5+ years of QC management experience in a cGMP environment with proven success in leading diverse teams.
• Experience with both analytical chemistry and microbiology operations.
• Strong understanding of global GMP regulations, compendial testing, method lifecycle management, and laboratory quality systems.
• Demonstrated ability to manage budgets, resources, and vendor relationships.
• Proven leadership in regulatory inspection preparation and execution.

Preferred Qualifications

• Advanced degree (M.S., Ph.D., or MBA)
• Sterile injectable and/or combination product experience.

California residents should review our
Notice for California Employees and Applicants
before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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