Job Title: Manager, Quality Assurance
Location: Montgomery, AL
This position is located at the Kowa Pharmaceuticals America, Inc. corporate office in Montgomery, AL. Applicants living in or near Montgomery, AL or willing to relocate to the area will be considered. Some relocation assistance may be provided.
The primary purpose of the Manager of Quality Assurance at Kowa Pharmaceuticals America, Inc. (KPA) is to support the company Quality Management System through management of the Quality Assurance activities regulated by FDA. The role will ensure KPA activities (e.g. product release, customer complaints, quality oversight) comply with applicable U.S. regulations, guidelines and company policies/procedures. This position will collaborate with Kowa Company Limited (KCL) in efforts to oversee, implement, monitor, and review activities at partner sites and facilitate access and interactions between KCL and external partners.
• Assists supervisor and other functional departmental staff in the implementation and maintenance of the Quality Management System at KPA for all FDA regulated activities;
• Primary responsibility is to maintain a company-wide quality system using appropriate process flow mapping, documentation, record keeping, and measurements;
• Manage quality events and actions (Process Deviations, CAPA) within a regulated Quality Management System, and help develop change management around new and enhanced workflows;
• Collaborates with functional department personnel to ensure that FDA regulated activities at KPA comply with U.S. regulations, ICH/GXP international guidelines, and internal policies and procedures, as applicable;
• Directly partner with the KCL on-site quality representative to ensure that commercial pharmaceutical and investigational product for human use is managed and released in timely and compliant manner;
• Collaboration with KCL on-site quality representative to provide occasional quality compliance support to medical device and commodity product efforts at KCL’s request.
• Reviews (and provides Quality Assurance sign-off) on GMP batch records, specifications, label proofs, protocols/reports, as assigned;
• Plans, promotes, and organizes training activities related to product quality and reliability;
• Maintains the overall KPA internal and external auditing process and schedule which include requirements for organizing, planning, scheduling, assignment and follow through on the timely review and completion of internal and external audit commitments;
• Oversees and/or conducts external vendor/supplier auditing including initial quantification and periodic re-qualification of external vendors/suppliers for KPA and KCL, as requested;
• Tracks follow-up/resolution of critical/major findings (Complaints/CAPAs/Deviations, Validation/Troubleshooting) associated with external vendor/supplier audits, as required;
• Acts as the primary point of contact for Quality Assurance between KPA and/or KCL and external vendors/suppliers ensuring optimal communication across companies in quality-related matters;
• Plans and performs internal KPA Warehouse Facility audits and other functional area audits, as scheduled, and oversees resolution of resulting corrective/preventative actions;
• Creates, revises, and reviews quality management system-related documents, including policies, standard operating procedures (SOPs), and guidelines for the Quality Assurance functional area and the overall Quality Management System;
• Reviews (and provides Quality Assurance sign-off) on functional department policies, SOPs, and guidelines to ensure compliance with applicable regulatory and industry standards;
• Provide oversight to change control by ensuring changes are developed, documented, authorized, implemented and monitored in compliance with all applicable procedures;
• Collaborate with Regulatory Affairs and Commercial Operations to determine the regulatory/product/process impact assessment of proposed changes;
• Communicate with customers and suppliers about continuous improvement expectations.
• Embody Kowa lean principles and methods while fostering a continuous improvement mindset throughout the organization;
• Support management in the handling of recalls and field corrective actions;
• Keeps up to date with current regulatory guidelines and compliance regulations;
• Abides by company policies regarding safety rules and regulations;
• Adapts to various situations and adjusts to shifting priorities;
• Performs other duties as assigned;
NOTE: The information presented, while not an exact or exhaustive listing, describes the work, performance standards, and qualifications typically required of employees in this job. A specific position description or employee performance plan may differ as long as it is consistent with the core responsibilities, standards and qualifications for that job. Nothing in this job description restricts management’s rights to assign or reassign duties and responsibilities to this job at any time.
Kowa is committed to provide equal opportunity employment, and advancement opportunities to all individuals. Kowa does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, protected veteran, pregnancy, status as a qualified individual with a disability, or any other characteristic protected by Federal, State, or Local Laws. Employment decisions at Kowa will be based on merit, qualifications, and abilities.
Experience and Skills Required:
• Bachelor of Science degree in chemistry, engineering, pharmacy, biology, manufacturing technology, or other technical area is required; an advanced degree is desirable;
• A minimum of 7 years of pharmaceutical, medical device or comparable industry quality experience is required (quality document management, product release, change control, deviation, CAPA, complaint resolution, auditing etc.).
• Knowledgeable of cGMP, PIC/S and/or Global Quality Requirements, SOP management and quality system processes (21 CRF 210/211, ICH-Q Series, ISO);
• Quality auditing, lean manufacturing, and validation experience is desirable;
• Ability to work with and across various organizations, organizational functions and levels is essential;
• Excellent oral and written communications skills, excellent problem solving abilities, accurate data entry, and exceptional organizational skills required;
• Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems;
•Capable of working in a team-oriented and rapidly changing environment.
Total Quality Management
Provide Technical Guidance