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 Sr. Director QA Compliance will be responsible for oversight and implementation of GMP quality systems in line with US, EU and Global regulations, guidance’s and best practices. This position will report directly to the V.P of Quality and Compliance. The successful candidate will be a hands-on self-starter with the ability to collaborate and work closely with various cross-functional teams to ensure quality cGMP standards are implemented and followed. The successful candidate will lead the QA staff and the site ensuring the company is prepared for any health authority inspections and to advise on changes needed to stay current with evolving global regulations. Lastly, the Sr. Director will be responsible for ensuring all operations relating to products or services meets the established standards and client requirements.
• Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures
• Lead cGMP QA oversight of ongoing manufacturing and testing operations as well as overall site operations e.g. facilities, building commissioning, supply chain, etc… assuring ongoing compliance with quality and industry regulatory requirements
• 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
• 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.
• Quality Systems Process and Program Development and Implementation.
• Facility commissioning, Factory Acceptance Testing/System Acceptance Testing.
• Equipment qualification and validation, IQ/OQ/PQ.
• Provide guidance and direction throughout electronic system implementations: Laboratory Information Management System (LiMS), Quality Management System (QMS).
• Ensure appropriate Qualification of vendors.
• Support any required implementation and ongoing compliance of computer systems through collaborative work with IT.
• As requested, provide QA review and feedback on regulatory submissions.
• Manage and develop QA staff and contractors.
• Effective interaction with stakeholders, customer services orientation, and teamwork
Education & Experience
• BS in Chemistry, Pharmacy, Biology or a related life science, or equivalent industry experience. Master’s degree 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.