Principal Quality Validation Specialist - 2399
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Key Responsibilities & Accountabilities:
- Responsible for leading the performance of quality review and approval of process, method, equipment, and computer system validation protocols and reports.
- Responsible for supporting the development of the cold chain validation strategy including the quality review and approval of validation protocols and reports.
- Responsible for the alignment of the Editas Quality Assurance Validation (QAV) strategy and content with internal and external clients.
- Complete understanding of industry practices for product lifecycle.
- Thorough knowledge and understanding of FDA and foreign validation requirements and expectations.
- Represent the QAV group in project teams, audits, and inspections.
- Responsible for supporting the development of process validation requirements for new product introductions through commercial scale.
- Provide subject matter expertise to scalable development of Editas internal QC lab along with assay/method development and method validation.
- Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
- Review and approve quality control method validation protocols, stability protocols, and associated reports.
- Provide QAV support/expertise to CMC and Tech Transfer teams.
- Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
- Ensures that all activities & related documentation comply with applicable regulations and Editas requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Drive Support Continuous improvement and Operational Excellence initiatives
- Support quality master data maintenance of Oracle Supply Chain Management and associated tools (e.g. barcoding solution).
- Assure Compliance of GxP digital systems in alignment with system regulations (21 CFR Part 11, GMP regulations, GAMP, Annex 11).
- Provide QA support and implementation expertise for the introduction of new computer systems following industry regulatory guidance and best practices.
- Assess data integrity across business systems through the utilization of tools, dashboards, and analytics to identify and mitigate risks, inconsistencies, and identify areas for continuous improvements.
- Supports the development of QAV departmental and Editas organizational long-range goals and objectives.
- Manage and mentor QA validation team and contractors to ensure department and company objectives are met.
Knowledge, Skills & Capabilities:
- A minimum of eight (8) years of validation experience in the pharmaceutical industry, including clinical through commercial drug product phase appropriate application.
- Thorough knowledge and experience in cGMP regulations (21 CFR Part 210/211/11) and guidelines (ICH Q7, Q8, Q9, Q10) and other international regulatory requirements relevant for process, cold chain, equipment, method, and digital system validation.
- Leadership skills to support QAV and cross functional team project success.
- Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
- Proficiency in the use of Microsoft Office, PowerPoint, and pharmaceutical GxP Digital Solutions.
- Demonstrated experience managing programs established to ensure the integrity of data across the organization.
- Good verbal and written communication skills
- Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
- Demonstrated organizational skills to managing multiple projects and priorities.
Education & Relevant Work Experience:
- BS Degree in Life Sciences or equivalent
- Minimum of 8 yrs. QA Validation or related experience
Physical & Travel Requirements:
- Travel 25% of the time
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.