Senior Manager, Quality Assurance Validation - 2465
Editas Medicine, United States

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Key Responsibilities amp; Accountabilities:

• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth.
• Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
• Review and approve the Validation Master Plan (VMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed, maintained and all supporting documentation is complete and accurate.
• Perform quality review and approval of manufacturing process, aseptic process, and shipping validation protocols, performance, and final summary report.
• Contribute to the development of procedures, business processes and tools for process qualification, and continuous process verification using industry best practices and adhering to industry standards.
• Responsible as a key subject matter expert supporting development of process validation requirements and strategy for current and new product introductions through commercial scale.
• Ensure relevant processes, equipment and systems are validated and the validated state is maintained throughout the equipment lifecycle.
• Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
• Manage the review and approval of quality control method validation protocols and associated reports.
• Contribute to the development of strategies related to the design, installation, commissioning amp; qualification, and process qualification of digital manufacturing strategies.
• Provide QA Validation support and expertise to CMC and Tech Transfer teams.
• Represent the Quality Assurance Validation group in project teams, audits, and inspections.
• Contribute to the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
• Drive Support Continuous improvement and Operational Excellence initiatives.
• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth.

Requirements

Knowledge, Skills amp; Capabilities:

• Expertise in biologic cGMP manufacturing, with experience in cell and gene therapy preferred.
• Demonstrated experience in execution of process validation programs from master plans through protocols and authoring reports.
• Thorough understanding of industry guidance, knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.
• Experience in leading a team of direct reports and providing guidance and mentorship to junior team members.
• Understanding of industry validation practices throughout the product lifecycle.
• Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
• Working knowledge of current Good Manufacturing Practices (cGMP 21 CFR Part 210/211) and Electronic Records; Electronic Signatures (21 CFR Part 11).
• A minimum of eight (8) years of experience in pharmaceutical manufacturing, manufacturing science amp; technology, technical development or Quality.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.
• Demonstrated organizational skills to managing multiple projects and prioriti

Job Rewards and Benefits