Job Information
RESILIENCE US INC Manager, Quality Assurance (Day Shift) in West Chester, Ohio
A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary & Responsibilities The Quality Assurance Manager will be accountable for all QA activities and decisions to directly support the workstreams across the site. These activities and decisions include batch release, change control, and documentation, equipment and process validation, deviation investigations, SOPs, and regulatory interactions and may also include incoming material inspection and release. This role will evolve to provide leadership, daily support, and supervision of GMP operations. The Quality Assurance Manager will develop quality on-the-floor programs to support GMP manufacturing, and the training of QA personnel, and also be responsible for overseeing the daily activities of QA staff. Job Responsibilities Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET) Accountable for all QA decision-making in the PETs; works with the PET leaders and other team members to deliver all PET and site objectives Provide direction, development, and performance management to the Quality professionals supporting the PET Accountable for the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and the equipment and facilities utilized by the PET: Change Management (Change controls) Batch Release decisions and material disposition Quality Investigations (Deviations, supplier deviations) Validation Plans, Protocols, and other technical reports reports Standard Operating Procedures & Risk Assessments Accountable for the release of incoming materials (bulk, APIs, excipients, packaging components, and so on.) Manage a team of up to approximately 10 -15 direct reports Support the site to ensure a safe working environment, including leading your team's safety efforts. Supervise, coach, and assist with employee development and performance management; ensurea fair and equitable workplace Collaborates with other managers and Quality professionals from other PETs (including other sites) to ensure consistent application of the key quality systems across all PETs Interfaces with the Site Support Groups on improvement projects (capital and noncapital) that impact the PET, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring, and consultation to the PET leader and PET members Ensures that the QA processes including batch record review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the workgroup Minimum Qualifications Experience in a position of people leadership Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies Ability to influence leaders in a matrix environment, as well as the personal conviction to make courageous decisions to ensure patient safety and safeguard the company's reputation. Preferred Qualifications Five years of experience in sup