Plant Quality Assurance Manager

　　The Plant QA Manager is a senior role within PQA and reports directly to the PQA Senior Manager. The PQA Manager will be responsible for leading and directing Quality staff, will be a Subject Matter Expert in their assigned area of responsibility and required to understand and grasp a broad range of quality related competencies.

　　Plant QA Manager Responsibilities

　　• Responsible for leading and directing Quality staff including managing their performance and supporting their development.

　　• Provide real-time QA oversight and support for production operations. This currently extends to formulation, Vial and Syringe Fill Finish aseptic operations.

　　• Collaborate with Operations to resolve quality and compliance issues, including but not limited to Change Controls, Deviations and CAPAs.

　　• Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, Maximo)

　　• Review and approve cGMP records (e.g., Deviations, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation.

　　• Alerts senior management of quality, compliance, supply and safety risks

　　Support and represent Quality during audits and inspections.

　　• Support Lean Transformation and Operational Excellence initiatives.

　　• Provides training and advice to staff for them to perform their desired functions.

　　The knowledge and skills necessary to perform the duties of the QA Manager are typically acquired through the following combination of education, experience, and knowledge.

　　Basic Qualifications

　　• University degree - Engineering or Science related discipline preferred.

　　• Relevant experience (8 yrs.+) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

　　• Technical skills and demonstrated competencies across a broad range of quality related disciplines.

　　Preferred Qualifications

　　• Experience working in aseptic operations, protein formulation, vial and syringe filling.

　　• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.

　　• Experience working with dynamic cross-functional teams and proven abilities in decision making.

　　• Experience in management or leadership roles

　　• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.

　　• Excellent written and verbal communication skills.

　　• Strong organizational skills, including ability to follow assignments through to completion.