Manager Quality Assurance, GMP Pharma

Company: ViziRecruiter,LLC.
Location: Aliso Viejo
Posted on: September 17, 2023

Job Description:

Industry: Medical Technology and Pharmaceutical Level: Full time Compensation: Base Salary Range: $109,100 - $158,100 Overview Position Summary The Quality Assurance Manager, GMP Pharma will implement strategy and promote effective operation of the quality assurance program for drug/device combination devices at Glaukos. This person will work in close partnership with the Company's R&D, Applied Research and Regulatory Affairs groups, and will be the interface with the Quality groups at the CMOs, as it relates to all quality assurance matters. Compensation Compensation for each successful candidate will be based on several factors, which may include qualifications, experience, education, talent availability, and local market conditions. Range listed is not inclusive of additional compensation such as bonus, equity, or additional benefits Responsibilities Quality Assurance Drug Combination Device Quality Management. Serve as GMP Quality Subject Matter Expert for assigned drug programs. Follow established quality systems procedures required for appropriate GMP compliance including change control, deviations, complaints, training, etc. Ensure supporting product, supplier and quality systems documentation is maintained in accordance with company and industry standards. Performance Perform quality assurance activities (such as validation protocol/report review and approval, specification review and approval, batch record review and release, etc.) to ensure timely delivery of DS, DP and finished (packaged and labeled) product to support the clinical development plan, as well as the commercial sales plan as appropriate. Perform and/or participate in internal audits, as assigned. Teamwork Participate on cross-functional teams, as needed. Participate in special projects as needed. Oversee Oversee quality aspects of pharmaceutical development in an outsourcing environment, for DS, DP and CTM, including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling, product release, distribution and associated stability programs, for assigned drug programs. Oversee supplier quality management activities for assigned suppliers. Support Support other objectives, as assigned. Provide back-up support to other members of the Quality Assurance department as appropriate and as needed. Compliance Oversight to include confirmation of compliance, management of quality audits and inspection readiness activities, and appropriate resolution of corrective and preventive action plans, as required. Procedure Follow established procedures for the oversight of quality aspects of pharmaceutical development in an outsourcing environment, for drug substance (DS), drug product (DP) and clinical trial material (CTM), including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, labeling product release, and associated stability programs for assigned drug programs. Requirements Education Bachelor's degree, preferably in a science or related field. Experience 8+ years industry experience in a leadership role. Demonstrated audit conduct and management experience is desired. Knowledge Working knowledge of technical and analytical aspects of pharmaceutical manufacturing. Working knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs. Working knowledge of technical, analytical aspects, and validation as applied to pharmaceutical manufacturing, testing and equipment. Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World. Skills Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding, fast-paced environment. Ability to exercise judgment with minimal guidance in making decisions to assure product quality and operational compliance. Demonstrated ability to implement procedures which ensure compliance to GMP and regulatory standards. Education Bachelor's degree, preferably in a science or related field. Experience 8+ years industry experience in a leadership role. Demonstrated audit conduct and management experience is desired. Knowledge Working knowledge of technical and analytical aspects of pharmaceutical manufacturing. Working knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs. Working knowledge of technical, analytical aspects, and validation as applied to pharmaceutical manufacturing, testing and equipment. Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World. Skills Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding, fast-paced environment. Ability to exercise judgment with minimal guidance in making decisions to assure product quality and operational compliance. Demonstrated ability to implement procedures which ensure compliance to GMP and regulatory standards. About UsFounded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the iStent --in the United States, followed by our next-generation iStent -inject - -device in September 2018 and iStent -inject - -W in September 2020.In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases. Legal Disclaimer: Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. view full text

Keywords: ViziRecruiter,LLC., Aliso Viejo , Manager Quality Assurance, GMP Pharma, Executive , Aliso Viejo, California