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## Quality Assurance ManagerApplylocations: Pennsville, NJtime type: Full timeposted on: Posted Yesterdayjob requisition id: R26\_568"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.**Your Role:**The incumbent is responsible for the management of all aspects of Quality Assurance and provides daily support and supervision to the Quality Assurance Specialists.**Your Profile:****ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES**:* Project team member and primary customer contact for quality decisions and product oversight. Liaison for quality issues and execution of product release.* Executes final release of product, ensuring batches meets all quality specifications and compliance requirements. Added responsibility for on-time release.* Directs QA resources and workflow with Production and Shipping.* Sets agenda scheduling and leads audits for external customers. Authors audit responses and ensures completion of associated CAPAs.* Performs and trains QA staff on performing internal audits* Provides QA leadership during technology transfers* Integral to the management of regulatory agency inspections. Incumbent oversees flow of information, is responsible for responding to inquiries and developing strategy for risk mitigation.* Prepares and tracks KPIs for upper management.* Authors Standard Operating Procedures/Work Instructions and implements process changes.* Decision-maker of quality requirements for change controls.* Designs project scope and compliance requirements for Product and Equipment Validations, Qualifications and Assessments documents. Authors reports with scientifically sound conclusions.* Acts as the primary liaison between QA and all other departments on day-to-day basis.* Oversees the flow of logs and turnaround in the Department.* Ensures QA requirements defined in Customer Quality Agreements are met.* Acts as the primary contact for projects or issues that involve QA.* Drives continuous improvement of GMP compliance and inspection readiness* Participates in Inventory meetings.* Prepares, reviews and approves Product Quality Reviews (PQRs) / Annual Product Reviews (APRs)* Reviews and approves change controls and ensure compliance with global change control procedures* Leads site readiness for regulatory inspections* Reviews and approves Master Production Records as appropriate.* Reviews and approves executed logs as appropriate.* Reviews and approves deviations, investigation reports and CAPAs.* Reviews and provides input to Drug Master Files (DMFs).* Manages Customer complaints, inquiries and complete requests pertaining to QA.* Participates in review and approval of all SOP’s that require QA signature.* Ensures appropriate training and GMP awareness across site personnel* Manages implementation and adherence to all applicable cGMP regulations.* Oversees Quality Systems department* Manages QA/QS budgets* Ensures Environmental Monitoring (EM) for the site is on track* Ensures that personal and departmental moral, ethical, legal, and behavioral conduct meets the Siegfried Code of Conduct.* Adheres to all applicable SHE regulations.**SUPERVISION:**The incumbent directly supervises 5 to 10 QA/QS Specialists and is responsible for staffing, performance management, and training of the direct reports.**EDUCATION AND EXPERIENCE:**-A BS degree in Chemistry, Chemical Engineering or equivalent technical field and/or 5-10 years’ experience in Quality Assurance for a pharmaceutical company-Two to five years of leadership experience is required. In-depth knowledge of cGMP in a manufacturing environment is a must.**OTHER REQUIREMENTS:**-Must have excellent verbal and written communication skills.-Must be able to work efficiently with people of all levels and cultures.-Must have excellent coaching and interpersonal relationship skills.-Must be conscientious and detail-oriented.-Must be a team player.-Must be a self-starter and initiator.-Must have excellent project management skills.**Your Benefits:****Additional Benefits*** Competitive performance-based bonus* Employee Share Matching Plan* 401(k) Match* Medical, Dental, and Vision Offerings* Life, Sickness and Accident insurance, and Long-term disability* Increased Voluntary Life Insurance (employee and family) (optional)* The salary for this role is anticipated to be between $105,000 and $135,000Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions #J-18808-Ljbffr