The Senior Manager of Quality Assurance will lead or be a primary partner in programs for quality oversight, aseptic manufacturing, and contamination control. The Senior Manager will work closely with the Director of Quality to develop a quality mindset and culture of effectiveness. The role requires exceptional interpersonal skills, written and oral communication skills, and the ability to navigate audits and identify operational and quality gaps.
Requirements
- Recruit, build, and lead a QA Operations Formulation & Filling team
- Responsible for training and maintaining an engaged work force competent in both theory and application of Quality processes
- Lead through coaching, mentoring, and maintaining an on-the-floor presence in operations to ensure rigorous quality work standards and quality product manufacture
- Lead development of room/line clearance processes for formulation and aseptic filling areas
- Train QA team members on gowning and area contamination controls, aseptic operational line process and equipment applications and verifications
- Lead strategy and direction of the Quality Assurance team to partner with Operations in the performance of on-the-floor batch record review and correction
- Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events
- Serve as a site subject matter expert in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools
- Partner with EH&S and Operations management in using positive and proactive approaches to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals
- Partner with Operations management in applying knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness on the operations floor
Benefits
- Competitive salary
- Benefits package
- 401(k) matching
- Tuition reimbursement
