CBM

Full Time EE

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

The 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).