Manager, Quality Control
Purpose and Scope
Join a globally renowned pharmaceutical firm specializing in cutting-edge long-acting injectable drug delivery systems. Their team is built on dedication to supporting partners, patients, and healthcare providers. Oversee the creation and execution of policies, processes, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Provide leadership and management to the Quality Control Chemistry team, including investigators, instrumentation lifecycle specialists, sampling personnel, and the laboratory administrator.
Essential Duties & Responsibilities
- Manage Laboratory Operations: Oversee daily QC Chemistry lab operations, ensuring quality standards and project timelines are met. This includes work prioritization, coordination with stakeholders, and communication with leadership.
- Compliance and Documentation: Supervise the generation, documentation, and compliance of deviations, investigations, CAPA change controls, and instrumentation. Ensure compliance with sample submission forms, periodic reviews, and regulatory requirements.
- Change Management and Continuous Improvement: Author, review, and approve controlled documents and change controls. Lead the department in evaluating and implementing new systems and training for continuous improvement.
- Resource and Budget Management: Review and approve purchase requests and invoices, ensuring budget adherence. Identify cost-saving measures and manage resources to support laboratory processes.
- Team Leadership and Development: Provide guidance and mentorship to staff, participate in hiring and retention, and recognize top-performing talent. Foster an atmosphere of teamwork and respect, and ensure technical and transferable skill development.
Knowledge, Skills & Abilities
- Leadership and Team Management: Excellent leadership and supervisory skills with the ability to coach, mentor, and develop staff. Demonstrated ability to create and maintain highly functioning teams and foster an atmosphere of teamwork and respect.
- Regulatory and Compliance Expertise: Expert knowledge of regulations related to deviations, investigations, CAPA, change control, and instrumentation. Extensive knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), GMPs, GLP, and cGMP for conformance to US, EU, and ROW standards.
- Technical Proficiency: Proficient in computer systems for sample tracking, laboratory equipment, raw data handling, and storage. Experience in conducting investigations, writing deviations, implementing CAPA, and initiating change controls.
Ready to make a difference? Join and be part of a team that's transforming the future of healthcare.
