This position ensures Pilot Plant operations and quality control functions comply with cGMP regulations (Japan, EU and US), Industry Standards and Client corporate quality expectations, and company’s hhc mission. This includes, but is not limited to, production, testing and disposition of Biological Drug Substance (BDS), raw materials and cell banks at Pilot Plant and at CMOs/CROs for clinical and commercial use. This position is also responsible for ensuring that the internal and external quality management system/processes will support cost effective provisions of BDS, raw materials and cell bank.
This position will be the key member of the Pilot Plant Commercialization Committee, to contribute to the strategic decisions and directions, and execute actions to establish readiness to manufacture and test BDS for commercial use by 2Q CY2020.
This position is also responsible for enhancing the relationship with the leadership in Pilot Plant to influence and ensure continuous quality improvement, and promote Quality Culture.
Collaborating with Medicine Development Center (MDC), Client Demand Chain System (EDCS), Global Product Quality Headquarter (GPQ), Americas Region (Commercial) Quality, Regulatory Affairs and external parties, this position is responsible to ensure that schedules for the release and distributions of BDS are met.
IND/IMPD creation/updates and auditing of source information is also an important role of this position.
1. Provide oversight and leadership to ensure that the quality of BDS for clinical and commercial use will comply with cGMP regulations (Japan, EU and US), Industry Standards and Client corporate quality expectations to ensure that the site is inspection ready.
2. Contribute to the strategic decisions and directions to establish readiness to manufacture and test BDS for commercial use as a delegate of Quality organization for the Pilot Plant Commercialization Committee. Execute actions as planned and assigned.
3. Direct management and teams to maintain QMS and/or continually evaluate current policies, procedures and practices to develop and implement improvements in the Pilot Plant.
4. Other examples of responsibility :
• Provide quality oversight to internal/external organizations for the manufacture and analysis of BDS, raw materials, cell banks and critical intermediates.
• Identify and report any critical quality incidents of BDS to DQA Head, subsequently to Chief Quality Officer(CQO) and Global Product Emergency Management (GPEM) Committee Chair. And execute the decisions made by Global Product Emergency Management (GPEM)
• Supervise people managers/individual contributors and provide guidance and leadership. Manage employee-related activities including performance management and development. Identify resource needs. Participate in recruitment, and compensation planning for assigned employees.
• Serve as the Quality contact for the site with regards to interactions with regulatory agencies and business partners. Leads regulatory inspections and partner audits.
• Develop department budget and ensure the department is committed to financial targets
• In partnership with senior management, establish a quality culture and philosophy at the site which will guide the development of policies, practices, procedures, and standards by which all site operations are performed; provide quality assurance input to Client strategic goals
• Facilitate the setting of both short-term and long-term goals of the QA operations group and ensure accountability for achieving results
• Bachelor degree in Biologic, Chemistry, Engineering or related sciences; Master degree preferred
• Minimum 12 years of experience in a cGMP environment for pharmaceutical products, including minimum 3 years of experience working with biologic products in commercial manufacturing
• Minimum 5 years of leadership experience in a Quality organization
• Advanced knowledge and experience with Quality Assurance, Quality Systems, QC and GMP regulations
• Advanced knowledge of manufacturing and testing Biologic Drug Substance (BDS)
• Advanced knowledge of current BDS related regulations and regulatory authority’s expectations
• Experience in facilitating and supporting regulatory audits (FDA, EMEA, PMDA, etc.) in support of pre-approval and general inspections
• Technical and scientific judgement
• Excellent problem solving and decision making abilities.
• Self -motivating individual comfortable working with detailed information and data
• Excellent organizational skills
• Excellent verbal/written communication and interpersonal skills
• Strong presentation skills
Source: Job Diva – Job Listing