Nucleus Healthcare Hiring For Director, Cell Therapy Qa Manufacturing Operations at King of Prussia, PA, United States Full Time

Job Description

SummaryThe Center for Breakthrough Medicines is looking for a quality expert to support the organization by establishing quality operational processes, quality systems, driving growth, and ensuring quality across cell therapy manufacturing operations. The Director of QA Manufacturing Operations will be responsible for the overall management of quality operations, audit readiness, data integrity, and document control supporting Cell Therapy product release for client services. This role will provide leadership, strategic thinking, and results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced environment and deliver exceptional service to our clients.Responsibilities Direct and oversee all aspects of QA manufacturing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs. Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions. Manage problems of varied scope using a high degree of prudence and risk-based decision making. Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities. Interpret industry regulations and guidance documents for the creation and implementation of quality standards, quality operational procedures and policies, and site procedures Partner with other business units or departments in support of continuous improvement initiatives. Author or revise SOPs to address gaps or necessary improvements to Quality Systems. Develop and provide cGMP and other GxP training as needed. Maintain knowledge of global regulatory requirements for the Cell and Gene Therapy products. Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance. Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization. Interact with the quality team and internal stakeholders to support the development, manufacturing, manufacturing, packaging and release of manufacturing products as needed. Additional duties as assigned.Qualifications Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products. Significant experience with both digital and paper based QMS solutions. Diverse Quality operations experience across functions in GMP including CRO/CDMO oversight activities. Regulatory experience a plus. Bachelor’ s Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred. Minimum of 10-15 years of progressive managerial experience within biopharmaceutical Quality Assurance. Cell and Gene Therapy industry experience is a plus. 10 years’ in-depth experience in GMP/GXP industry. In-depth knowledge of risk management systems and/or computer systems validation programs strongly preferred e.g., Veeva, Labware (LIMS), SAP Previous experience preparing for and leading client audits and/or regulatory inspections. Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action. Planning and organizational skills – able to establish objectives and schedule tasks and resources efficiently. Communication skills – strong written communication skills to provide concise and clear documentation. Partner with other business units or departments in support of continuous improvement initiatives. A hands-on leader who can perform day-to-day QA activities as well as direct others to perform such work. Excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management. Ability to provide solution minded approach and flexibility to emerging challenges. Able to appropriately balance priorities plus multitask against competing priorities. Certifications is an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma Knowledge of tools, concepts and methodologies of QA Solid experience in effective usage of data analysis tools and statistical analysis Proficient in Microsoft Office (Excel, Word, Outlook).#IND1Job Type: Full-timeSchedule:

• Monday to Friday

Ability to commute/relocate:

• King of Prussia, PA 19406: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• How many years of experience do you have with CGT?

Education:

• Bachelor’s (Required)

Experience:

• CGMP: 8 years (Required)
• Quality assurance: 8 years (Required)
• Quality management: 8 years (Required)

Work Location: One location