Quality Systems Manager

Quality Systems Manager The Quality Systems Manager oversees the process and management of quality systems, deviation management, change control, risk, documentation, supplier management, and system housekeeping. This role serves as the primary point of contact for customer audits and regulatory inspections, establishes CAPA plans, and executes them on time. The manager is responsible for the Quality Management System ownership, including dashboard reporting, and identifies areas for continuous improvement while providing strong leadership over a multidisciplinary team. Responsibilities Human Resources Management Ensure the team’s training is appropriate for executing missions. Conduct annual interviews to assess development and performance. Define priorities for resources and deadlines. Develop team skills and autonomy. Quality Management System Process Ownership Ensure consistency and maintenance of the quality management system. Maintain compliance with customer requirements, internal rules, regulatory requirements, and GMPs. Address deviations identified during audits/inspections and implement corrective actions. Periodically present results of the Quality Management Process and suggest improvement areas. Update the quality manual in line with system changes. Coordinate site housekeeping through internal audits and regular site visits. Prepare for audits and lead or participate in customer audits and regulatory inspections. Respond as SME to audit inquiries. Propose and lead or participate in site and quality improvements. Change Control Management Oversee the change management process. Lead the change control committee and reach consensus with stakeholders. Ensure compliance with the change management procedure. Monitor action items and ensure timely closure. Approve changes. CAPA and Action Item Management Ensure timely implementation of actions after deviations, complaints, and recurrences. Approve the consistency and effectiveness of all action plans. Ensure closure of action plans. Deviations Management Analyze recurrent failure causes and lead the periodic recurrence committee. Lead or participate in troubleshooting teams, define action plans with relevant departments, and propose improvement areas. Investigate recurring issues identified in recurrence meetings. Self‑Inspection and Internal Audit Management Formalize audit schedule based on risk approach and justify priorities. Ensure audit schedule follow‑up and justify deviations. Support auditors in audit preparation, deviation classification, response development, and action implementation. Ensure continued training of the internal audit team. Risk Management and Annual Product Review Management Formalize yearly risk assessment schedule and ensure completion. Collect, analyze, and discuss data, identify appropriate action plans. Ensure content complies with applicable standards and site quality policy. Quality Software Administration (EnnovDoc and Track Wise) Manage upgrades, changes, and maintain system documentation. Create and modify user accounts. Set up system according to procedures. Oversee resolution of user issues. Provide quality software training. Documentation System Management Ensure paper and electronic diffusion of documents. Handle document modifications and updates. Monitor document awareness among users. Manage document archives and destruction of expired documents. Suppliers’ Management Maintain supplier qualifications for raw materials and packaging components. Define supplier management strategy, write and maintain procedures. Set audit schedule based on risk, manage costs, and justify variations. Evaluate supplier audit reports and approve action plans. Participate in supplier approval and board meetings. Maintain the Approved Supplier List. Handle supplier complaints and propose action plans. People Leadership & Talent Management Responsibilities Lead and oversee staff performance, annual evaluations, coaching, mentoring, and goal setting. Conduct managerial touchpoints to reinforce expectations and engagement. Partner with HR for workforce planning, staffing needs, and candidate selection. Participate in succession planning and development initiatives. Support onboarding, training, and continuous development. Adjust to evolving business needs and HR-driven initiatives. Foster a culture of accountability, inclusion, engagement, and continuous improvement. Qualifications Bachelor’s degree required; Master’s preferred. 10+ years in a quality role. 5+ years of management experience. Strong knowledge of quality practices in GMP and federally regulated environments. Scope of Decision‑Making: Requires complex analytical judgment and independent decision making with general knowledge of company policies and procedures, application to non‑routine cases, and substantial influence over the area of responsibility. Level of Supervision: Direct supervision of 1–10 employees. Internal/External Contacts: Regular contact with subordinates, other departments, and occasional external contacts, including customers/clients. Physical Requirements: Facility mobility, 60% sitting, 40% standing/walking, slight lifting, computer keyboard use, hearing and vision to read documents, occasional irregular hours and travel. Compensation Range 130,000.00 – 143,000.00 USD The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hours will be set within the range, considering factors such as market data, education, experience, qualifications, and internal equity. Benefits 100% employer‑paid medical premiums (approximately $2,000–$6,000+ annual value). 401(k) contributions: 6% match plus additional 4% company‑funded contribution. HSA contributions with wellness incentives. Annual performance bonuses and merit increase eligibility. Additional benefits designed to reward impact, not just hours worked. Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants. #J-18808-Ljbffr