QA Manager - 22966BR - EN

Ensure the compliance of manufacturing and testing activities with respect to Sage procedures as well as FDA, EU, HC, ICH, and other regulatory expectations and requirements.
Ensure that Quality System procedures are followed (auditing, change control, corrective and preventive actions, deviations and general investigations, etc.)
Oversee batch record review and lot disposition activities for release of all manufactured lots including components and products.
Oversee the Incoming Quality Assurance Department and all activities for release of component lots and calibration of equipment.
Provide quality input for failure analysis, problem solving, risk assessment and mitigation activities related to the manufacture or testing of intermediates and products. Continuously assess the impact of changes on quality management system and quality of products.
Develop and implement enhancements to the Quality Management System procedures.
Establish appropriate Quality Assurance goals to effectively measure departmental and quality system results.
Prepare and present reports for Management review.
Provide quality oversight of contract manufacturing organizations, including providing on-site quality decision-making during drug product formulation and filling activities.
Provide support where required for the Supplier Qualification Program with respect to components and excipients used for drug product manufacture.
Provide oversight of curriculums for the Employee Training Program.
Provide support for external regulatory or partner GMP audits (i.e. planning, preparation, conduct / execution and responding to deficiencies or observations)
Act as a QA subject matter expert by providing technical and quality guidance to peers, Operations and other departments as necessary.
Administer personnel (including but is not limited to: time cards, performance review, etc.).
Coach and develop Quality Associates and promote a positive quality culture throughout the facility by establishing sound systems and maintaining process focus.
Perform other duties as assigned.
Job Requirements
Bachelor's Degree with at least five (5) years of Quality Assurance related experience in a current Good Manufacturing Practices (cGMP) environment.
Experience managing manufacturing investigations and utilizing and administering electronic quality management systems (e.g. Agile).
Experience managing staff including administration and professional development.
Possess effective communication (verbal and written) and strong interpersonal and teamwork skills.
The ability to interact with internal and external customers (e.g. partners and vendors), regulatory Authorities and Inspectors.
Skills to manage multiple priorities with aggressive timelines and with a high level of productivity.
An ability to be productive and successful in an intense work environment.
Experience with LEAN tools and concepts preferred.
Strong computer skills required

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