Senior Manager, Quality Systems

Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.

We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.

Scope of Responsibilities:

•Hire, develop and train an agile Quality Assurance - Systems team capable of implementing Quality Assurance - Systems processes to support cutting edge technologies for cell therapy, vector manufacturing and fill finish.

•Develop and implement the Quality Assurance - Systems program in support of the internal Quality Management System including GMP procedures and processes to support cutting edge technologies for cell therapy, vector manufacturing and fill finish.

•Review of GMP documentation to support the Quality Systems including Document Management, Change Control, Deviations, CAPA, Supplier Management, Risk and Audits.

•Support the implementation and quality oversight of GMP digital systems in a phase appropriate manner for the company.

•Ensure phase-appropriate compliance with cGMP regulations, guidance, and industry standards.

•Establish meaningful performance objectives and create a culture of continuous improvement.

•Actively develop staff and provide regular coaching and feedback. 

•Partner closely with colleagues in Process Development, Manufacturing, and Quality Control to ensure effective technology transfers and right-first-time performance.

•Review and approve GMP manufacturing documentation including Standard Operating Procedures, Quality Records, and other documentation as applicable.

•Collaborate to close out deviations and change controls and ensure timely implementation of preventative and corrective actions.

•Ability to multitask and flexible to change utilizing risk-based and business-risk management techniques.

•Ability to readily shift priorities based on immediate needs.

Qualifications:

•Bachelor's degree in engineering, biology, chemistry, or a related field.

•8+ years of experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.

•4+ years of effective management and strong leadership experience, with an excitement to both roll up your sleeves and be a thoughtful, company-wide partner.

•Extensive working knowledge of cGMP requirements and phase appropriate systems.

•Ability to manage and prioritize tasks and projects. 

•Excellent verbal/written communication skills.

•Ability to multi-task, manage projects and track status to completion.

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.