Manager of Manufacturing Quality
As the Manager of Manufacturing Quality, you will be responsible for the oversight and leadership of the Manufacturing Quality team responsible for routine support of facility sterile manufacturing operations. This includes floor oversight, internal auditing, batch-related documentation review/approval, and qualification/validation support. The Manager of Manufacturing Quality will support, manage, and oversee the quality and compliance of facility manufacturing activities while supporting continuous improvement initiatives.
- Lead the oversight, review, and approval of all Manufacturing Quality related documents including, but not limited to, change control, specification review/approval, API/excipient/component release, master record review/approval, executed batch record review, product release, deviation/investigation approval, and validation approval.
- Develop and ensure execution of the internal Quality audit schedule.
- Develop site Quality metrics and lead Quality metrics discussion during periodic Management Review.
- Provide support as required for external audits, client audits, and regulatory inspections.
- Provide support and guidance to Manufacturing Quality, Validation, Engineering, and Facilities as warranted.
- Provide strategic review and continuous improvement of Manufacturing 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.
- Bachelor’s degree or higher is required, preferably in the technical/scientific field, e.g., engineering, chemistry, biology, or mathematics.
- A minimum of ten years of Manufacturing Quality experience in a pharmaceutical manufacturing facility (sterile manufacturing preferred)
- A minimum of 6 years of direct management experience.
- Broad-Based technical knowledge of aseptic processing, cGMPs, and FDA/EMA regulatory requirements. Working knowledge of process 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.