Manager, Quality Control Laboratory

About the role

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.

Responsibilities

- 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

Requirements

- Bachelor’s degree with 10 years of pharmaceutical Quality experience (preferably in QC) or an equivalent combination of education and experience

Qualifications

- Experience in pharmaceutical Quality Assurance - Strong knowledge of quality systems and regulatory requirements - Excellent organizational and project management skills - Ability to lead and mentor a team - Proficient in Microsoft Office Suite - Strong analytical and problem-solving skills

Skills

- Knowledge of Good Manufacturing Practices (GMP) - Familiarity with laboratory equipment and techniques - Strong communication and interpersonal skills - Ability to work independently and as part of a team

Benefits

- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) - Participation in long-term incentive programs - Equal opportunity employer

Pay

109500 - 208500 USD