Director Quality Operations
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).
- 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:
-Complaints and Recalls
-Validation and Maintenance
-QA support of Third Party Manufacturing
-Quality Control Laboratories
-Batch Review and Product Disposition
-PQR / APR preparation
-Quality relevant IT systems
-GMP and on-the-job training system
-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 GMP and on-the-job programs) are established and maintained to support regulatory and Company requirements
- Coordinates activities and leads interactions during regulatory agency inspections, notified third party audits, and customer audits.
- Provides oversight of audit conduct and reporting, including allocation of appropriate audit resources
- Coordinates activities and leads the Annual Product Review/Product Quality Review process for FPG QA. Schedules, plans, and coordinates with other FPG (and third party providers) the required information to effectively prepare and approved the APR/PQR by the required due dates
- Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to the organization, and works to remediate any identified gaps or improvements
- Lead projects or participate in projects related to the general area of QA’s responsibilities
- Performs other duties / projects as assigned by the Vice President, US Quality Assurance.
- Minimum of a Bachelor of Science degree in Life Sciences or related discipline, or pharmacy from an accredited college or university.
- A minimum of 15 years of equivalent experience in a regulated industry such as pharmaceutical, biologic or device required with 10 or more years’ experience in Quality.
- Direct experience working in at least two of the following cross functional, GMP areas is required: GMP QA, Supplier Quality, External Manufacturing QA, Quality Control, Manufacturing or Technical Services.
- Solid experience with effectively managing FDA and other regulatory inspections, working with regulators, and vendor audits is essential.
- Experience with, and good understanding of, FDA and other key regulatory agency inspection procedures, inspection preparation and management, and addressing inspectional findings is also required.
- Full understanding of GMPs and the pharmaceutical development process is required as well as transfer of processes and methods from development to scale-up and scale-up to commercialization is necessary.Broad knowledge of risk-based Quality Systems’ components is required.
- Certified Lead Auditor (ASQ or ISO) is highly preferred
- MS Office applications, Trackwise, LIMS is highly preferred