Manager, Quality Control Laboratory

Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team!

Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future  are better together and together We Are Altasciences.

The Manager, Quality Control (QC) Laboratory oversees the laboratory activities and ensures the highest standards of accuracy, efficiency, and compliance. The incumbent plays a critical role in team leadership and operational management and directly influences the laboratory’s growth and alignment with pharmaceutical industry standards and regulatory requirements.

QC Laboratory activities cover but are not limited to the following main tasks:

• Finished Product Release Testing
• In Process Control (IPC) Testing
• Finished Product Stability Testing
• Stability Program
• Raw Materials Testing (Internal and External Testing)
• Method Development and Validation (Phase II/III and Commercial Products)
• Environmental Monitoring (Internal and External Testing)
• Cleaning Verification Testing
• Cleaning Method Validation

Provide strategic and day-to-day leadership for GMP Quality Control Laboratory operations, including commercial, and clinical phase II/III supply. Manages the QC Laboratory team providing growth opportunities for staff and accomplishing results by communicating job expectations, planning, monitoring, and appraising job performance. Develop, coordinate, and enforce department systems, policies, procedures, and productivity standards, to ensure optimal performance as well as robust operational strategies that will enhance service delivery and client satisfaction.

Communicates QC Laboratory Key Performance Indicators to Site Leadership Team and General Manager. Maintains compliance with all relevant GMP regulatory requirements and laboratory certifications. Formulate and manage laboratory budget, ensuring cost-effectiveness and resource optimization targeting resources allocated for the QC Laboratory profit center. Identify opportunities to improve efficiency, reduce costs, and increase throughput without compromising quality. Maintain continuous engagement with key clients, ensuring alignment with their evolving needs.

Enforce rigorous health and safety standards to protect staff and ensure environmental compliance. Review and approve analytical method validation protocols and reports, test procedures, stability protocols, and development reports. Participate in review and approval of GMP change controls. Review and advise on analytical investigations of OOS and OOT results in a cGMP environment. Propose, enact, and enforce corrective actions. Schedules and executes on time the QC Laboratory work plan in compliance with Quality requirements.

Oversees capacity planning, resource allocation, and laboratory readiness to support current and future client demand. Ensures full compliance with FDA, EPA, DEA, OSHA and other regulatory requirements. Partners with Quality to support audits, inspections, and regulatory submissions covering the QC Laboratory activities. Owns QC laboratory related deviations, OOS investigations, CAPAs, and change controls. Promotes a strong culture of quality, data integrity, and regulatory compliance within the laboratory.

Acts as a key QC Laboratory representative for client engagements, technical discussions, and governance meetings. Ensures QC laboratory execution meets contractual obligations, timelines, and quality expectations. Support technology transfer activities and scale-up from development to commercial manufacturing. Build, lead, and develop high-performing QC laboratory teams,…