The Quality Control Laboratory Manager is responsible to ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director.
- Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
- Member of the Laboratory Center of Excellence (COE)
- Serves as the standalone laboratory systems and site Maximo administrator
- Reviews and approves raw materials and commodities including ERP approval
- Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
- Qualification and validation protocol writing, review, and approval
- Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
- Provides front room and laboratory SME support during regulatory agency and internal inspections
- Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
- Leads the implementation of Quality-related projects including metrics
- Bachelor’s degree in Science is required.
- Must have at least 10 years of pharmaceutical Quality Control experience
- Strong technical knowledge in Raw Material compendia testing, verification, and interpretation.
- In-depth knowledge in analytical instrumentation, technique, and problem-solving
- Ability to drive a large group of people to keep them motivated while increasing performance
- Strong knowledge in bioanalytical testing such as ELISA, CESDS, TNF HPLC, etc.
- Demonstrated leadership of a highly complex, fast-paced program demonstrated critical thinking, agility, and change management.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced