NJ Employer Director, Quality Operations in PARSIPPANY, New Jersey

JOB DESCRIPTION: Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women s health (obstetrics/gynecology) and orthopaedics. Ferring s US operations employ approximately 800 people. People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science. SUMMARY: The Director, Quality Operations will manage all activities of the Quality Operations department and have overall responsibility for the development, administration and maintenance of the quality system (and operations) encompassing the Company s commercial manufacturing operations. Shall maintain a favorable regulatory compliance position (GxP) pertaining to all aspects of commercial manufacturing operations. Is responsible for communicating quality issues to department head and may communicate to executive management, including resource requirements. Will prevent and mitigate quality risks which can jeopardize Ferring's interests (patient safety, supply continuity, reputation). Drive continuous improvement efforts through tracking and trending of key quality metrics and performance indicators. Prevent and mitigate quality risks which can jeopardize Ferring's interests (patient safety, supply continuity, reputation). RESPONSIBILITIES: * Provide senior leadership and direction for the Quality Operations Department (QA, QC, Microbiology) to ensure the attainment of corporate and local objectives. * Develops, coaches, mentors staff to ensure business goals and development plans are met.Establish current and long-range plans and objectives required to assure corporate and operational-level compliance. * Assure all quality processes are deployed and maintained in accordance with GxP, policies and procedures, * Responsible for planning and budgeting pertaining to Quality Operations activities.Responsible for the review and approval of executed batch records and associated data and records. Final release and disposition of final packaged product for shipping to offsite warehouse. Meet department metric for schedule adherence. * Leads and maintains acceptable compliance for all Quality systems, including: -Deviations, OOS -Complaints and Recalls -Validation and Maintenance -Change Control -QA support of Third Party Manufacturing -Quality Control Laboratories -Stability investigations -Internal audit -Batch Review and Product Disposition -PQR / APR preparation -Quality relevant IT systems -GMP and on-the-job training system -Management Review -Metric tracking, trending, continuous improvement * Perform all surveillance processes including planning, execution, and generation of reports for internal and external audit programs. * Prioritize and communicate findings to auditee/audited sites and escalate significant issues to executive management, as required. Compile all audit findings and monitor for signals and trends,Reviews and approves documents as required, including protocols, reports, document changes, etc. * Assures that SOPs related to QA are updated * Leads Quality Review Board reporting and monitoring for local GXP compliance to established metrics. Ensures adequate actions are taken in response to quality issues and follow-up for their effectiveness. Identifies areas for improvement and modifies QRB process, where necessary * Ensures department training system (including G