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Director (Associate Director), QA & Regulatory
2 months ago
We are seeking a highly motivated, dedicated, and results driven Quality and Regulatory professional to join the team to fill a new leadership role supporting ancillary and cellular starting materials for the development and further manufacture of advanced therapy products in domestic and global markets. This hands-on Director/Associate Director will direct a Quality team and QC team to continued success as a company. You would be great for this role if you have shown a commitment to the growth of your career and to the success of your past employers and have a proven track record in cGMP compliance, maintaining an inspection ready quality management systems. In this role you will be interfacing across the company as well as with external customers, collaborators, and vendors. Most importantly, you should be a dedicated professional with a drive for personal excellence and a willingness to assume increasing responsibilities as the company grows.
Essential Job Duties
Provide strategic direction and leadership to a top-performing Quality Assurance team to foster a culture of continuous learning and development.
Responsible for the Quality Management System, lot release functions, and operational management of all QA activities to assure the overall quality of company's products.
Build external relationships with and oversee management of contract manufacturing organizations.
Ensure compliance with relevant regulations and guidelines, including FDA, EMA, and other international regulatory authorities and requirements.
Identify and assess quality risks associated with the business and develop risk mitigation strategies and ensure their effective implementation.
Contribute to department goals by driving implementation of Quality objectives and delivering key results.
Support/lead initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
Hands on execution of Quality tasks to support Quality Operations
Support the generation/compilation of CMC Regulatory content of Master Files for clinical-grade media and cell banks.
Skills/Qualifications:
Bachelor's or higher degree with a minimum of 7+ years of cGMP Quality experience.
Experience in biologics is a must; cell therapy or ATM experience is a plus
Global Regulatory experience that spans from early-stage to commercial
Strong leadership and people management skills, with the ability to inspire and continuously develop a high-performing team.
Proven track record in maintaining the highest standards of safety, quality, and operational excellence.
Excellent communication and interpersonal skills, with the ability to effectively support customers, external vendors and partners, as well as internal cross functional collaboration at all levels of the organization.
Proven and discernable decision making ability with confidence to uphold quality and safety.
Able to manage multiple priorities and aggressive timelines with a sense of urgency yet be flexible enough to adapt to changing priorities while maintaining a positive and collaborative attitude.
