There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
The Discovery Labs, Center for Breakthrough Medicines, is looking for a quality expert to support the organization by establishing quality systems, driving growth, and ensuring quality across site testing operations. The Director of QA Testing Operations will be responsible for the overall management of the data review release supporting Cell and Gene Therapy product release as well as testing 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.
• Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures.
• Data analysis - able to collect and analyze data to identify trends and detect problems and key issues
• 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.
• Author or revise SOPs to address gaps or necessary improvements to Quality Systems.
• Develop and provide cGMP and other GxP training as needed.
• Review the implementation, execution and effectiveness of the quality systems and inspection processes e.g. documentation of internal audits and other quality assurance activities, investigations, customer complaints, CAPA’s and non-conformance issues.
• 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.
• Oversee all aspects of QA testing 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.
• Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging and release of manufacturing products as needed.
• 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.
• Additional duties as assigned.
Education & Experience
• Bachelor' s Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred.
• Minimum of 10 years of progressive managerial experience within biopharmaceutical Quality Assurance. Cell and Gene Therapy industry experience is a plus.
• 8-10 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 regulatory inspections.
• 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).