CRISPR seeks a Quality Assurance professional to support the company’s QA Compliance program. As part of the CRISPR Supplier Quality Management team, the successful candidate will perform a broad range of external and internal audits and take part in the development and improvement of existing Quality Systems to ensure the QMS operates in compliance with applicable regulations, guidelines, and management expectations. In addition, the candidate will participate in sustaining inspection readiness at CRISPR and continuous QA improvement measures.
Compliance Audits (external) = 40%
- Perform supplier risk assessments to establish appropriate audit frequency.
- Manage smooth execution of audits by arranging audit dates, preparing audit agenda, and scheduling kick-off/close out meetings with internal and external stakeholders.
- Conduct supplier qualification or for-cause audits of GMP service providers including raw material suppliers, Contract Manufacturing Organization, and Contract testing laboratories.
- Evaluate Supplier Quality systems and practices to identify potential problems such as non-conformance to applicable Quality Standards (GMP, ICH, GLP, etc.). Coordinate resolutions and provide guidance on quality/compliance risk levels as appropriate.
- Author audit reports, ensuring they are clear and cover the most important information to support successful development of CAPA’s.
- Communicate audit findings, including compliance risks, to external and internal stakeholders. Recommend approval or disapproval of suppliers based on compliance assessment.
- Review and evaluate auditee responses versus current industry standards and guidelines
- Track auditee CAPA commitments and assess effectiveness.
- Prepare audit performance metrics and trends to identify potential risks and CAPA effectiveness.
- Ensure all audit documentation is appropriately archived.
Compliance Audits (internal) = 40%
- Act as Lead Auditor or as a member of an internal audit team for Gap Assessment Audits (including training file audits, process audits, etc.).
- Develop internal audit agenda; coordinate audits with internal groups.
- Prepare audit reports and communicate findings to internal stakeholders.
- Provide recommendations to management regarding results of audit and compliance risk levels.
- Review and evaluate internal audit responses to ensure applicable compliance.
- Drive closure of corrective and preventative actions in a timely manner confirming appropriate documentation, implementation, compliance and continuing efficacy are maintained.
- Track audit responses and auditee CAPAs.
Regulatory Inspection Support = 10%
- Prepare for and support regulatory audits, client audits, or mock inspections by acting as scribe, reviewing documents, preparing operational staff to answer question, etc.
- Maintain current knowledge of Health Agencies regulations and guidance documents.
- Help ensure key operational groups are maintaining an on-going state of inspection readiness.
Compliance Department Support = 10%
- Negotiate Quality Agreements with Contract Manufacturers, Suppliers and Distributors.
- Maintain annual internal and external audit schedules, and audit internal files and databases to ensure all documentation is complete and up to date.
- Lead and/or support QA continuous improvement projects.
- Assist in and/or lead the development of new and revised Quality Compliance SOPs, Forms, or WIs, and provide Quality training as required.
- Assist with trending and reporting of external and internal audit metrics for inclusion in periodic Management Reviews.
- Positively impact the company by maintaining Quality through successful contributions, identification of compliance gaps, and being an advocate for Quality Compliance.
- A bachelor’s degree with a minimum of 8 years’ experience in the Pharmaceutical Industry subject to FDA and International Health Agency regulations and guidelines.
- Minimum of 5 years of internal and/or external GxP auditing experience.
- Knowledge interpreting and implementing United States Code of Federal Regulations, ICH Guidelines, EU regulations, and other local government regulatory requirements governing cGMP operations.
- Demonstrated experience in the conduct and reporting of audits, and the translation of findings into corrective action plans that mitigate risks to the company.
- Demonstrated ability to effectively organize and execute tasks.
- Strong oral and written communication skills.
- Able to lead cross-functional teams in conducting audits and resolving issues.
- Effective time management skills including the ability to adjust and manage multiple tasks with changing priorities/assignments.
- Ability to work in a dynamic, fast-paced environment where multiple projects are in process and must be completed in a timely manner.
- Able to be diplomatic, tactful and detail-oriented with exceptional critical reasoning skills.
- Able to deal with ambiguity and demonstrate a creative and pragmatic approach to problem solving.
- Able to travel domestically and/or internationally up to 20% of the time.
- Certification as a CQA Auditor, CQE, etc.
- BS or advanced degree in Biological Sciences or related fields.
- Advanced working knowledge of Health Agencies GLP/GCLP/GCP regulations and guidelines, including 21 CFR Part 11, and their appropriate application to various situations.
- Experience in GCLP and GCP audits in a variety of categories both domestically and internationally.
- Experience with allogeneic and autologous Gene/Cell Therapy Products
- Experience in Quality Operations oversight of external GxP service providers.