Manager of Laboratory Quality
As the Manager of Laboratory Quality, you will be responsible for the oversight and leadership of the Laboratory Quality team. This includes GMP data review, internal auditing, protocol/SOP/method validation review/approval, deviation review/approval, laboratory investigation review/approval, and laboratory instrument qualification/validation support. The Manager of Laboratory Quality will support, manage, and oversee the quality and compliance of the GMP Analytical and Microbiology laboratory activities while promoting continuous improvement initiatives.
- Lead the oversight, review, and approval of all Laboratory Quality related documents including, but not limited to, change controls, specifications, GMP data, SOPs, protocols, method validation, deviations, investigations, and equipment qualification/validation.
- Develop and ensure execution of the internal Quality audit schedule as it relates to laboratories.
- Develop laboratory Quality metrics to align with Manufacturing Quality KPIs.
- Lead a discussion of Laboratory Quality metrics during periodic Management Review.
- Provide support as required for external audits, client audits, and Regulatory inspections
- Provide support and guidance to Manufacturing Quality, Laboratory Quality, and Validation as warranted.
- Provide strategic review and continuous improvement of Laboratory Quality processes, training, and related procedures.
- Maintain a culture of high employee engagement, collaboration, flexibility, and competitiveness by increasing business and scientific understanding, industry knowledge, and execution skills.
- Ensure Policies and Standard Operating Procedures are in alignment with both organizational and compliance standards.
- Bachelors’ degree or higher is required, preferably in the technical/scientific field, e.g., engineering, chemistry, biology, or mathematics
- Ten years of Laboratory Quality experience supporting a pharmaceutical manufacturing facility (sterile manufacturing preferred)
- Six years of direct management experience
- Broad-Based technical knowledge of testing for aseptically processed/lyophilized products, cGMPs, and FDA/EMA regulatory requirements.
- Working knowledge of Microbiology is also preferred
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.