Assistant Director, GxP Quality Systems (QA Vendor Management)

Role Summary

ASSISTANT DIRECTOR, GxP QUALITY SYSTEMS (QA VENDOR MANAGEMENT)

Summary We are seeking an experienced Assistant Director with strong knowledge and expertise in Quality Systems, Vendor Management and External / Internal Audit Programs, with emphasis on Computer System Validation (CSV) and Data Integrity Audits. The ideal candidate will be highly motivated, detail-oriented, inquisitive and can proactively lead and be responsible for activities, assignments, and completing tasks in accordance with established expectations and timelines. This role is for an individual contributor reporting to the Director, GxP Quality Systems – Vendor Management.

Responsibilities

• Lead and execute Internal Audit Program in accordance with established procedures and through application of risk management to always ensure site compliance and inspection readiness.
• Independently lead and execute GMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices.
• Lead and manage Quality Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with GMP vendors.
• Manage Vendor Change Notifications collaborating with customers / stakeholder regarding impact and quality assessments and ensuring adherence to vendor change timelines and internal / regulatory requirements, as applicable.
• Lead investigations and/or analyze and trend Vendor Quality Events (i.e., Deviations including CAPA management and effectiveness checks, as required).
• Adhere to standard process lead times and ensures alignment with key performance indicators and relevant measures / metrics.
• Possess strong intra- / inter-company communication skills, ability to think critically and influence others, problem solve, and have solid technical writing skills.
• Demonstrate ability to work independently, be organized, multi-task and adjust priorities in a dynamic, fast paced work environment.
• Collaborate with others while leading projects that drive continuous quality improvements, implement best practices and /or enhance compliance to domestic and international regulatory requirements.

Requirements

• B.S. in Chemistry, Chemical Engineering, or a relevant Life Science degree; advanced degree preferred
• Requires a minimum of 8 years in the Life Sciences or Pharmaceutical industry with relevant Quality Assurance experience and 5+ years of GMP Vendor Management experience; or an advanced degree with lesser experience or alternate equivalent work experience
• Expert knowledge of domestic and international GMP regulations
• Experience in leading projects, problem solving, process improvement with strong negotiation skills
• Experience and understanding of product formulation and filling, and assembly of drug delivery devices (i.e., combination products), is preferred
• Experience and understanding of Antisense Oligonucleotide manufacturing processes is desired
• Committed to delivering high quality results, overcoming challenges, focusing on what matters to achieve corporate, department and personal goals and objectives
• Continuously looking for opportunities to learn, build skills and share learnings both internally and externally
• Travel up to 20% may be required